Anesthesia; Adverse Effect, Anesthesia Complication, Anesthesia Intubation Complication, Anesthesia Morbidity, Anesthesia; Reaction, Dysphagia, Dysphonia, Intubation Complication, Sore-throat, Throat Disorder, Throat Injury, Throat; Wound
Conditions
Keywords
Endotracheal tube, Anesthesia, Sore throat, Throat pain, Dysphonia, Dysphagia, Throat injury, General anesthesia, Intubation, Endotracheal intubation, Breathing tube, Odynophonia, Odynophagia
Brief summary
The purpose of the study is to test a novel endotracheal tube support device that reduces pressure of the tube on the voice box for prevention of post intubation laryngeal symptoms including sore throat, change in voice and trouble swallowing.
Detailed description
Single center randomized controlled trial with 100 subjects who will be intubated for already planned surgeries. The participants will be randomized into the control group or the clip group. The clip group will have a small clip (the endotracheal tube support device) placed on the endotracheal tube to reduce the pressure on the vocal cords and larynx. This endotracheal tube support device is made from a FDA approved biocompatible material. The control group subjects will undergo their planned procedure with no intervention during intubation. The clip group will undergo their planned procedure as normal but with the endotracheal tube support device placed on the endotracheal tube by the assigned anesthesia attending physician. The clip is placed once the tube is secured and the ventilator circuit is connected. While extubating the patient, the endotracheal tube will be removed with the clip attached and a picture of the tube will be taken to record the clip location. Before the planned procedure, the investigators will survey the participants to get a baseline for any pre-existing laryngeal symptoms. The same survey will be administered after the procedure when the participants are awake and alert just prior to discharge, 24 hours, 48 hours, and 1 week after the procedure. The survey will ask the participant to indicate yes or no for whether they are experiencing a sore throat, throat pain, oral pain, difficulty speaking, difficulty swallowing, changes in their voice, pain while speaking, and pain while swallowing. If they have indicated yes for any of the symptoms, the participants will also be asked to mark the severity on a visual analog scale from 1 to 10. Other data points will also be collected in this study that are related to the intubation and participant's airway. The investigators will record the total time of the procedure and the length of time the clip is placed on the endotracheal tube. For each participant in the clip group, the investigators will also record the time it takes to place the clip on the endotracheal tube. Each participant's airway will be evaluated, and the investigators will record the thyromental distance, Mallampati score, history of difficult intubation, and the size of the endotracheal tube used. Lastly, data from each participant's intubation will be collected including number of attempts before successful intubation, incidence of dental injury, incidence of lip injury, laryngeal view on Cormack-Lehane scale, and any noted trauma upon extubation. Lastly, the investigators will have the anesthesiologists recruited for the study fill out a modified National Aeronautics and Space Administration (NASA) Task Load Index (TLX) form to evaluate the end-user experience for the device.
Interventions
DEVICEEndoClip
Clip attached to mid portion of the endotracheal tube.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patient will not be aware of their treatment arm. Investigator and Care Provider will be aware of treatment are but data analysis (outcomes assessor) will be blinded to treatment groups.
Intervention model description
2 arm parallel trial where one group will receive the endotracheal tube clip during general endotracheal anesthesia and the other group will not.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient undergoing general endotracheal anesthesia with an endotracheal tube * Patient is not undergoing a procedure in the head and neck region
Exclusion criteria
* Patient with pre-existing severe sore throat, voice change, or trouble swallowing * Patient undergoing surgery in the head and neck region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Baseline to 1 week after intervention | Subjects will indicate whether they are experiencing a sore throat or throat discomfort on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no sore throat) to 10 (worst possible sore throat). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study. |
| Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Baseline to 1 week after intervention | Subjects will indicate whether they are experiencing a change in voice (i.e. deep and/or hoarse voice, worse than their usual voice quality) on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no voice change) to 10 (most severe voice change). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study. |
| Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Baseline to 1 week after intervention | Subjects will indicate whether they are experiencing difficulty swallowing on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty swallowing) to 10 (complete inability to swallow). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study. |
| Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Baseline to 1 week after intervention | Subjects will indicate whether they are experiencing mouth pain on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no mouth pain) to 10 (worst possible mouth pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study. |
| Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Baseline to 1 week after intervention | Subjects will indicate whether they are experiencing difficulty talking on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty talking) to 10 (complete inability to talk). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study. |
| Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Baseline to 1 week after intervention | Subjects will indicate whether they are experiencing pain in the anterior or low region of the neck and/or chest on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study. |
| Patients With Post Operative Mouth Pain | 7 days | Patients with post operative mouth pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below. |
| Patients With Post Operative Sore Throat | 7 days | Patients with post operative sore throat during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below. |
| Patients With Post Operative Neck/Chest Pain | 7 days | Patients with post operative neck/chest pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below. |
| Patients With Post Operative Voice Change | 7 days | Patients with post operative voice change over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below. |
| Patients With Post Operative Difficulty Talking | 7 days | Patients with post operative difficulty talking over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below. |
| Patients With Post Operative Difficulty Swallowing | 7 days | Patients with post operative difficulty swallowing over there first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below. |
Countries
United States
Participant flow
Recruitment details
100 subjects recruited in an outpatient surgery center at University of California San Diego Health from November 2022 to September 2023.
Participants by arm
| Arm | Count |
|---|---|
| EndoClip Clip applied to endotracheal tube.
EndoClip: Clip attached to mid portion of the endotracheal tube. | 50 |
| No Clip No clip applied to endotracheal tube. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | EndoClip | Total | No Clip |
|---|---|---|---|
| Age, Continuous | 55 years | 52 years | 48 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 21 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 79 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 31 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 55 Participants | 28 Participants |
| Region of Enrollment United States | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 22 Participants | 53 Participants | 31 Participants |
| Sex: Female, Male Male | 28 Participants | 47 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change)
Subjects will indicate whether they are experiencing a change in voice (i.e. deep and/or hoarse voice, worse than their usual voice quality) on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no voice change) to 10 (most severe voice change). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Time frame: Baseline to 1 week after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoClip | Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Day 0 - after intubation on day of discharge | 1.87 score on a scale | Standard Deviation 2.12 |
| EndoClip | Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Day 1 - day after intubation | 1.13 score on a scale | Standard Deviation 1.66 |
| EndoClip | Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Day 2 - 2 days after intubation | 0.59 score on a scale | Standard Deviation 1.14 |
| EndoClip | Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Day 7 - 7 days after intubation | 0.26 score on a scale | Standard Deviation 0.8 |
| No Clip | Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Day 7 - 7 days after intubation | 0.27 score on a scale | Standard Deviation 0.7 |
| No Clip | Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Day 0 - after intubation on day of discharge | 2.21 score on a scale | Standard Deviation 2.79 |
| No Clip | Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Day 2 - 2 days after intubation | 0.83 score on a scale | Standard Deviation 1.46 |
| No Clip | Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) | Day 1 - day after intubation | 1.30 score on a scale | Standard Deviation 2.17 |
p-value: 0.18t-test, 1 sided
Primary
Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow)
Subjects will indicate whether they are experiencing difficulty swallowing on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty swallowing) to 10 (complete inability to swallow). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Time frame: Baseline to 1 week after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoClip | Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Day 0 - after intubation on day of discharge | 1.04 score on a scale | Standard Deviation 2.16 |
| EndoClip | Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Day 1 - day after intubation | 0.58 score on a scale | Standard Deviation 1.49 |
| EndoClip | Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Day 2 - 2 days after intubation | 0.20 score on a scale | Standard Deviation 0.68 |
| EndoClip | Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Day 7 - 7 days after intubation | 0.1 score on a scale | Standard Deviation 0.58 |
| No Clip | Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Day 7 - 7 days after intubation | 0.49 score on a scale | Standard Deviation 1.46 |
| No Clip | Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Day 0 - after intubation on day of discharge | 1.21 score on a scale | Standard Deviation 2.16 |
| No Clip | Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Day 2 - 2 days after intubation | 0.94 score on a scale | Standard Deviation 1.97 |
| No Clip | Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) | Day 1 - day after intubation | 1.13 score on a scale | Standard Deviation 2.14 |
p-value: 0.007t-test, 1 sided
p-value: 0.04t-test, 1 sided
Primary
Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk)
Subjects will indicate whether they are experiencing difficulty talking on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty talking) to 10 (complete inability to talk). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Time frame: Baseline to 1 week after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoClip | Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Day 1 - day after intubation | 0.35 score on a scale | Standard Deviation 1.36 |
| EndoClip | Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Day 7 - 7 days after intubation | 0.1 score on a scale | Standard Deviation 0.42 |
| EndoClip | Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Day 2 - 2 days after intubation | 0.29 score on a scale | Standard Deviation 1 |
| EndoClip | Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Day 0 - after intubation on day of discharge | 0.87 score on a scale | Standard Deviation 1.96 |
| No Clip | Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Day 1 - day after intubation | 0.96 score on a scale | Standard Deviation 1.96 |
| No Clip | Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Day 0 - after intubation on day of discharge | 1.09 score on a scale | Standard Deviation 2.11 |
| No Clip | Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Day 2 - 2 days after intubation | 0.61 score on a scale | Standard Deviation 1.43 |
| No Clip | Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) | Day 7 - 7 days after intubation | 0.27 score on a scale | Standard Deviation 0.7 |
p-value: 0.04t-test, 1 sided
Primary
Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain)
Subjects will indicate whether they are experiencing mouth pain on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no mouth pain) to 10 (worst possible mouth pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Time frame: Baseline to 1 week after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoClip | Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Day 1 - day after discharge | 0.06 score on a scale | Standard Deviation 0.32 |
| EndoClip | Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Day 7 - 7 days after intubation | 0.02 score on a scale | Standard Deviation 0.14 |
| EndoClip | Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Day 2 - 2 days after intubation | 0.04 score on a scale | Standard Deviation 0.29 |
| EndoClip | Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Day 0 - after intubation on day of discharge | 0.07 score on a scale | Standard Deviation 0.33 |
| No Clip | Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Day 2 - 2 days after intubation | 0.27 score on a scale | Standard Deviation 1.19 |
| No Clip | Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Day 1 - day after discharge | 0.28 score on a scale | Standard Deviation 0.77 |
| No Clip | Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Day 0 - after intubation on day of discharge | 0.42 score on a scale | Standard Deviation 1.58 |
| No Clip | Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) | Day 7 - 7 days after intubation | 0.12 score on a scale | Standard Deviation 0.39 |
p-value: 0.03t-test, 1 sided
p-value: 0.04t-test, 1 sided
Primary
Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain)
Subjects will indicate whether they are experiencing pain in the anterior or low region of the neck and/or chest on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Time frame: Baseline to 1 week after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoClip | Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Day 0 - after intubation on day of discharge | 0.37 score on a scale | Standard Deviation 1.44 |
| EndoClip | Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Day 1 - day after intubation | 0.25 score on a scale | Standard Deviation 0.96 |
| EndoClip | Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Day 2 - 2 days after intubation | 0.16 score on a scale | Standard Deviation 0.51 |
| EndoClip | Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Day 7 - 7 days after intubation | 0.06 score on a scale | Standard Deviation 0.31 |
| No Clip | Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Day 7 - 7 days after intubation | 0.29 score on a scale | Standard Deviation 1.08 |
| No Clip | Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Day 0 - after intubation on day of discharge | 0.77 score on a scale | Standard Deviation 2.08 |
| No Clip | Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Day 2 - 2 days after intubation | 0.71 score on a scale | Standard Deviation 1.83 |
| No Clip | Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) | Day 1 - day after intubation | 0.68 score on a scale | Standard Deviation 1.77 |
p-value: 0.02t-test, 1 sided
Primary
Patients With Post Operative Difficulty Swallowing
Patients with post operative difficulty swallowing over there first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoClip | Patients With Post Operative Difficulty Swallowing | 31 participants with symptoms |
| No Clip | Patients With Post Operative Difficulty Swallowing | 60 participants with symptoms |
p-value: <0.001Chi-squared
Primary
Patients With Post Operative Difficulty Talking
Patients with post operative difficulty talking over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoClip | Patients With Post Operative Difficulty Talking | 24 participants with symptoms |
| No Clip | Patients With Post Operative Difficulty Talking | 49 participants with symptoms |
p-value: <0.001Chi-squared
Primary
Patients With Post Operative Mouth Pain
Patients with post operative mouth pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoClip | Patients With Post Operative Mouth Pain | 6 participants with symptoms |
| No Clip | Patients With Post Operative Mouth Pain | 24 participants with symptoms |
p-value: <0.001Chi-squared
Primary
Patients With Post Operative Neck/Chest Pain
Patients with post operative neck/chest pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoClip | Patients With Post Operative Neck/Chest Pain | 16 participants with symptoms |
| No Clip | Patients With Post Operative Neck/Chest Pain | 35 participants with symptoms |
p-value: <0.001Chi-squared
Primary
Patients With Post Operative Sore Throat
Patients with post operative sore throat during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoClip | Patients With Post Operative Sore Throat | 65 participants with symptoms |
| No Clip | Patients With Post Operative Sore Throat | 82 participants with symptoms |
p-value: 0.007Chi-squared
Primary
Patients With Post Operative Voice Change
Patients with post operative voice change over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoClip | Patients With Post Operative Voice Change | 66 participants with symptoms |
| No Clip | Patients With Post Operative Voice Change | 67 participants with symptoms |
p-value: 0.39Chi-squared
Primary
Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat)
Subjects will indicate whether they are experiencing a sore throat or throat discomfort on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no sore throat) to 10 (worst possible sore throat). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.
Time frame: Baseline to 1 week after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoClip | Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Day 0 - after intubation on day of discharge | 1.85 score on a scale | Standard Deviation 2.44 |
| EndoClip | Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Day 1 - day after intubation | 1.1 score on a scale | Standard Deviation 1.52 |
| EndoClip | Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Day 2 - 2 days after intubation | 0.53 score on a scale | Standard Deviation 1 |
| EndoClip | Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Day 7 - 7 days after intubation | 0.18 score on a scale | Standard Deviation 0.69 |
| No Clip | Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Day 7 - 7 days after intubation | 0.43 score on a scale | Standard Deviation 1.25 |
| No Clip | Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Day 0 - after intubation on day of discharge | 1.9 score on a scale | Standard Deviation 2.34 |
| No Clip | Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Day 2 - 2 days after intubation | 1.12 score on a scale | Standard Deviation 1.94 |
| No Clip | Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) | Day 1 - day after intubation | 1.62 score on a scale | Standard Deviation 2.22 |
p-value: 0.03t-test, 1 sided