Intubation
Conditions
Brief summary
This study is for patients who will be having surgery and will have a breathing tube placed during intubation. The purpose of the research is to study the time it takes to use a barrier box for placement of a breathing tube. A barrier box is a clear box that sits over the head and shoulders of a patient as a breathing tube is placed. The box is used to protect the healthcare provider's exposure to coronavirus in patients who have COVID-19. The study will not include patients who test positive for COVID-19 or who are sick with COVID-19 symptoms. The researchers want to learn how long it takes to use the barrier box before it is used routinely in COVID-19 patients.
Detailed description
The study will have two groups of 39 patients in each group. Some patients will have a barrier box and some patients will not have a barrier box. Patients will be randomly assigned to the barrier box or no barrier box group. The study will measure the time it takes to place the breathing tube.
Interventions
OTHERBarrier box
Placement of barrier box ( a plastic box for shielding)
Sponsors
The Guthrie Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants assigned to barrier box or no barrier box
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients presenting for surgery needing general anesthesia with endotracheal intubation * pre-operatively tested negative for SARS- CoV-2 virus
Exclusion criteria
* inability to consent or cooperate, * children * pregnant women * patients with severe cardiopulmonary compromise * American Society Anesthesiologists' (ASA) physical status 4 and 5 * Body Mass Index (BMI) \>35 * known or anticipated difficult airway * patients with positive COVID status or unknown COVID status * patients who reported claustrophobia in the pre-operative area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubate | up to 2 minutes during intubation before surgery | Time to intubate refers to the time it takes to insert a tube into a patient's trachea to help them breathe. Intubation is a procedure routinely used before surgery to help keep the airway open. The study will compare the time to intubate in two groups, barrier box and no barrier box. In medical terms, time to intubate is the time from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation in First Attempt | up to 2 minutes during intubation before surgery | All participants were intubated successfully on the first attempt. |
| Need for Bag Mask Ventilation | up to 5 minutes | During induction time, there were no patients who needed bag mask ventilation. Bag mask ventilation is a technique used to provide oxygen and ventilation to patients who are not breathing adequately. Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator. |
| Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation) | up to 5 minutes | During process of inserting a tube in a patient's trachea (intubation) before surgery and the process of being given anesthesia (induction), there is a point where a patient's blood oxygen level drops to its lowest point during the process. This is referred to as the lowest oxygen saturation. In medical terms this is the lowest peripheral capillary oxygen saturation during the induction time defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator. The maximum blood oxygen level is 100%. Normal range is 95% - 100%. Low oxygen level (hypoxemia)is below 95%. |
| Induction Time | up to 5 minutes | Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Airway Assessment by Thyromental Distance (TMD) | Up to 5 minutes | Thyromental Distance (TMD) is the distance from the thyroid notch to the chin when the head is extended. TMD is used to assess and prepare for possible difficult intubation. A distance of greater than 3 finger breadth may be less likely to have a difficult intubation. A distance less than or equal to 3 finger breadth may be more likely to have a difficult intubation. Number of participants with TMD greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box). |
| Airway Assessment by Inter Incisor Distance | Up to 5 minutes | Inter incisor distance is the distance between the upper and lower teeth of the open mouth of a patient. Inter incisor distance is used to assess and prepare for possible difficult intubation of participants who are less than or equal to 3 finger breadth. A distance greater than 3 finger breadth may be less likely to have a difficult airway or airway constriction. Number of participants with Inter incisor distance greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box). |
| Neck Range of Motion | Up to 5 minutes | Neck range of motion is the degree of movement in the neck - how much the head can flex (bend forward), extend (tilt backwards), and rotate side to side. Neck range of motion helps assess and prepare for possible difficult intubation. Full range of motion is less likely for a difficult intubation. Restricted range of motion indicates a possible difficult intubation. Number of patients with Neck range of motion (categorized as full or restricted) will be assessed in both groups (Barrier Box and No Barrier Box) |
| Airway Assessment by Mallampati Score (Scale of 0 to 4) | Up to 5 minutes | Airway assessment by Mallampati score (scale of 0 to 4) used to assess and prepare for possible difficult intubation of participants who score high. Lower scores are less likely to have a difficult intubation and higher scores are more likely to have a difficult intubation. Mallampati 0: Any part of the epiglottis is visible Mallampati 1: soft palate, uvula, and pillars are visible Mallampati 2: soft palate and uvula are visible Mallampati 3: only the soft palate and base of the uvula are visible Mallampati 4: only the hard palate is visible. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Barrier Box Participants will have a barrier box placed during intubation
Barrier box: Placement of barrier box ( a plastic box for shielding) | 38 |
| No Barrier Box Participants will have routine intubation with no barrier box | 38 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Equipment problem during intubation | 0 | 1 |
| Overall Study | surgery cancelled | 1 | 0 |
Baseline characteristics
| Characteristic | Barrier Box | No Barrier Box | Total |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 16.7 | 52.7 years STANDARD_DEVIATION 18.9 | 55.2 years STANDARD_DEVIATION 17.8 |
| American Society of Anesthesiology (ASA) Physical Status ASA 1 | 1 Participants | 2 Participants | 3 Participants |
| American Society of Anesthesiology (ASA) Physical Status ASA 2 | 21 Participants | 25 Participants | 46 Participants |
| American Society of Anesthesiology (ASA) Physical Status ASA 3 | 16 Participants | 11 Participants | 27 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 38 participants | 38 participants | 76 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
Time to Intubate
Time to intubate refers to the time it takes to insert a tube into a patient's trachea to help them breathe. Intubation is a procedure routinely used before surgery to help keep the airway open. The study will compare the time to intubate in two groups, barrier box and no barrier box. In medical terms, time to intubate is the time from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.
Time frame: up to 2 minutes during intubation before surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barrier Box | Time to Intubate | 52.1 seconds |
| No Barrier Box | Time to Intubate | 42.0 seconds |
Secondary
Induction Time
Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.
Time frame: up to 5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barrier Box | Induction Time | 65.9 seconds |
| No Barrier Box | Induction Time | 67.7 seconds |
Secondary
Intubation in First Attempt
All participants were intubated successfully on the first attempt.
Time frame: up to 2 minutes during intubation before surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Barrier Box | Intubation in First Attempt | 38 Participants |
| No Barrier Box | Intubation in First Attempt | 38 Participants |
Secondary
Need for Bag Mask Ventilation
During induction time, there were no patients who needed bag mask ventilation. Bag mask ventilation is a technique used to provide oxygen and ventilation to patients who are not breathing adequately. Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.
Time frame: up to 5 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Barrier Box | Need for Bag Mask Ventilation | 0 Participants |
| No Barrier Box | Need for Bag Mask Ventilation | 0 Participants |
Secondary
Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation)
During process of inserting a tube in a patient's trachea (intubation) before surgery and the process of being given anesthesia (induction), there is a point where a patient's blood oxygen level drops to its lowest point during the process. This is referred to as the lowest oxygen saturation. In medical terms this is the lowest peripheral capillary oxygen saturation during the induction time defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator. The maximum blood oxygen level is 100%. Normal range is 95% - 100%. Low oxygen level (hypoxemia)is below 95%.
Time frame: up to 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Barrier Box | Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation) | 98.7 percentage of blood oxygen | Standard Deviation 2.6 |
| No Barrier Box | Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation) | 98.8 percentage of blood oxygen | Standard Deviation 2.6 |
Other Pre-specified
Airway Assessment by Inter Incisor Distance
Inter incisor distance is the distance between the upper and lower teeth of the open mouth of a patient. Inter incisor distance is used to assess and prepare for possible difficult intubation of participants who are less than or equal to 3 finger breadth. A distance greater than 3 finger breadth may be less likely to have a difficult airway or airway constriction. Number of participants with Inter incisor distance greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box).
Time frame: Up to 5 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Barrier Box | Airway Assessment by Inter Incisor Distance | Inter incisor distance less than or equal to 3 finger breadth | 0 Participants |
| Barrier Box | Airway Assessment by Inter Incisor Distance | Inter incisor distance greater than 3 finger breadth | 38 Participants |
| No Barrier Box | Airway Assessment by Inter Incisor Distance | Inter incisor distance less than or equal to 3 finger breadth | 0 Participants |
| No Barrier Box | Airway Assessment by Inter Incisor Distance | Inter incisor distance greater than 3 finger breadth | 38 Participants |
Other Pre-specified
Airway Assessment by Mallampati Score (Scale of 0 to 4)
Airway assessment by Mallampati score (scale of 0 to 4) used to assess and prepare for possible difficult intubation of participants who score high. Lower scores are less likely to have a difficult intubation and higher scores are more likely to have a difficult intubation. Mallampati 0: Any part of the epiglottis is visible Mallampati 1: soft palate, uvula, and pillars are visible Mallampati 2: soft palate and uvula are visible Mallampati 3: only the soft palate and base of the uvula are visible Mallampati 4: only the hard palate is visible.
Time frame: Up to 5 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 1 | 3 Participants |
| Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 3 | 6 Participants |
| Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 2 | 29 Participants |
| Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 4 | 0 Participants |
| Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 0 | 0 Participants |
| No Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 4 | 0 Participants |
| No Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 0 | 0 Participants |
| No Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 1 | 3 Participants |
| No Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 2 | 31 Participants |
| No Barrier Box | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Mallampati 3 | 4 Participants |
Other Pre-specified
Airway Assessment by Thyromental Distance (TMD)
Thyromental Distance (TMD) is the distance from the thyroid notch to the chin when the head is extended. TMD is used to assess and prepare for possible difficult intubation. A distance of greater than 3 finger breadth may be less likely to have a difficult intubation. A distance less than or equal to 3 finger breadth may be more likely to have a difficult intubation. Number of participants with TMD greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box).
Time frame: Up to 5 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Barrier Box | Airway Assessment by Thyromental Distance (TMD) | TMD greater than 3 finger breadth | 38 Participants |
| Barrier Box | Airway Assessment by Thyromental Distance (TMD) | TMD less than or equal to 3 finger breadth | 0 Participants |
| No Barrier Box | Airway Assessment by Thyromental Distance (TMD) | TMD greater than 3 finger breadth | 38 Participants |
| No Barrier Box | Airway Assessment by Thyromental Distance (TMD) | TMD less than or equal to 3 finger breadth | 0 Participants |
Other Pre-specified
Neck Range of Motion
Neck range of motion is the degree of movement in the neck - how much the head can flex (bend forward), extend (tilt backwards), and rotate side to side. Neck range of motion helps assess and prepare for possible difficult intubation. Full range of motion is less likely for a difficult intubation. Restricted range of motion indicates a possible difficult intubation. Number of patients with Neck range of motion (categorized as full or restricted) will be assessed in both groups (Barrier Box and No Barrier Box)
Time frame: Up to 5 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Barrier Box | Neck Range of Motion | Full | 36 Participants |
| Barrier Box | Neck Range of Motion | Restricted | 2 Participants |
| No Barrier Box | Neck Range of Motion | Full | 38 Participants |
| No Barrier Box | Neck Range of Motion | Restricted | 0 Participants |