Secretion Removal Above ETT Cuff
Conditions
Keywords
suction, aspiration, general anesthesia, intubation, endotracheal tube, respiratory complications
Brief summary
The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation, amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia in the operating room (OR). Studies in the intensive care unit (ICU) have demonstrated a significant reduction in the incidence of ventilator acquired pneumonia when a ETT with suction above the cuff is used to remove secretions that accumulate above the inflated cuff. This will be the first study to evaluate the efficacy of above the cuff suctioning during general anesthesia and surgery. One hundred and ten adult patients undergoing elective abdominal surgery (general, colorectal or gynecological) requiring general anesthesia with an endotracheal tube and mechanical ventilation will be randomized into 3 groups to receive one of the following three endotracheal tubes: 1. Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port Endotracheal Tube (Teleflex ISIS ETT). 2. Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT). 3. Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT) The first two groups will be compared to standard ETT (third group) regarding easy of tracheal intubation, efficacy of suctioning of secretions, efficacy of sealing the trachea with an inflated ETT cuff by preventing the movement of test dye (methylene blue) from the pharynx into the trachea and incidence of post-operative respiratory complications.
Interventions
DRUGmethylene blue
A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.
Sponsors
Teleflex
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective abdominal surgery with an anticipated duration longer than 2 hours. * ASA (American Society of Anesthesiologists) Physical status Classification 1 to 3. (1 - normal healthy patient, 2 - patients with mild systemic disease, 3 - patients with severe systemic disease) * Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment
Exclusion criteria
* Short duration surgery (anticipated \< 2 hours) or emergency (non-elective) surgery * ASA Physical status Classification 4 to 5. (4 - patients with severe systemic diseases that is a constant threat to life, 5 - Moribund patients who are not expected to survive without the operation) * Anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea. * Pregnancy * History of allergic reaction to Methylene Blue medication * Methemoglobinemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency * History of symptomatic chronic obstructive pulmonary disease (asthma, bronchitis, emphysema) or recent pneumonia (\< 6 months prior to surgery). * Hypoxemia (hemoglobin oxygen saturation \< 90% room air or on O2 at home or in hospital) * History of coagulopathy, IV heparin therapy, or coumadin therapy (INR \> 2.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery | 4 hours | The primary objective of the pilot study is to evaluate whether there is a difference between the 3 types of ETT in preventing the movement of test dye (methylene blue) from the pharynx into the trachea, past the inflated cuff. After tracheal intubation a small amount of methylene blue will be instilled into patients' pharynx every 60 minutes. The presence or absence of blue dye above and below the ETT cuff will be evaluated every 20 minutes using a video recording fiberoptic bronchoscope. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 4 hours | Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap. We will evaluate whether there is a difference in the pH of the aspirate between two ETT with suction above the cuff port. |
| the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT | 1 hour | Time to intubate trachea |
| Evaluation the Trachea and Vocal Cords at the Time of ETT Extubation to Determine Whether There is a Difference in the Amount of Mucosal Injury Between the 3 Types of ETT. | 4 hours | number of patients with mucosal injury and blood below the vocal cords |
| Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 4 hours | Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap. |
| Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 4 hours | Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap. The number of patients with a bacterial load of the aspirate between two ETT with suction above the cuff port was measured by gram stain of the aspirated secretions. |
Countries
United States
Participant flow
Pre-assignment details
We did initial 10 roll-in subjects to be familiar with all of the procedures and recordings.
Participants by arm
| Arm | Count |
|---|---|
| TaperGuard Evac ETT Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff
methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated. | 17 |
| Teleflex ISIS ETT Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff
methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated. | 17 |
| Standard ETT Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)
methylene blue: A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated. | 16 |
| Total | 50 |
Baseline characteristics
| Characteristic | TaperGuard Evac ETT | Teleflex ISIS ETT | Standard ETT | Total |
|---|---|---|---|---|
| Age, Continuous | 53.88 years STANDARD_DEVIATION 8.62 | 55.53 years STANDARD_DEVIATION 15 | 54.56 years STANDARD_DEVIATION 12.85 | 54.66 years STANDARD_DEVIATION 12.15 |
| ASA I | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| ASA II | 12 Participants | 9 Participants | 8 Participants | 29 Participants |
| ASA III | 5 Participants | 6 Participants | 6 Participants | 17 Participants |
| BMI | 28.40 kg/m^2 STANDARD_DEVIATION 3.25 | 26.23 kg/m^2 STANDARD_DEVIATION 4.12 | 26.85 kg/m^2 STANDARD_DEVIATION 4.41 | 27.16 kg/m^2 STANDARD_DEVIATION 3.92 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 8 Participants | 22 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 8 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 17 | 1 / 17 | 1 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 16 |
Outcome results
Primary
Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery
The primary objective of the pilot study is to evaluate whether there is a difference between the 3 types of ETT in preventing the movement of test dye (methylene blue) from the pharynx into the trachea, past the inflated cuff. After tracheal intubation a small amount of methylene blue will be instilled into patients' pharynx every 60 minutes. The presence or absence of blue dye above and below the ETT cuff will be evaluated every 20 minutes using a video recording fiberoptic bronchoscope.
Time frame: 4 hours
Population: the number of participants with dye in the distal trachea. One bronchoscopy recording was corrupted and not able to be evaluated in the GEvac group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TaperGuard Evac ETT | Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery | 0 number of participants with dye |
| Teleflex ISIS ETT | Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery | 0 number of participants with dye |
| Standard ETT | Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery | 2 number of participants with dye |
Secondary
Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap. The number of patients with a bacterial load of the aspirate between two ETT with suction above the cuff port was measured by gram stain of the aspirated secretions.
Time frame: 4 hours
Population: Only two groups that had suction above the cuff had the collected secretions and were analyzed. The specimen was Gram Stained and the presence of any bacteria/organisms was recorded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TaperGuard Evac ETT | Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 13 Participants |
| Teleflex ISIS ETT | Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 13 Participants |
Secondary
Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap. We will evaluate whether there is a difference in the pH of the aspirate between two ETT with suction above the cuff port.
Time frame: 4 hours
Population: Average Secretion pH
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TaperGuard Evac ETT | Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 7.38 pH | Standard Deviation 0.59 |
| Teleflex ISIS ETT | Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 7.29 pH | Standard Deviation 0.41 |
Secondary
Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Secretions will be continuously suctioned from the suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Teleflex ISIS ETT) into a Luken's trap.
Time frame: 4 hours
Population: Total Secretion Volume collected in Luken's trap. NO data for standard groups since there was no suction port in the standard ETT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TaperGuard Evac ETT | Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 13.00 mL | Standard Deviation 10.48 |
| Teleflex ISIS ETT | Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery | 26.00 mL | Standard Deviation 19.01 |
Secondary
Evaluation the Trachea and Vocal Cords at the Time of ETT Extubation to Determine Whether There is a Difference in the Amount of Mucosal Injury Between the 3 Types of ETT.
number of patients with mucosal injury and blood below the vocal cords
Time frame: 4 hours
Population: Extubation bronchoscopy data. some data are not available in all groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TaperGuard Evac ETT | Evaluation the Trachea and Vocal Cords at the Time of ETT Extubation to Determine Whether There is a Difference in the Amount of Mucosal Injury Between the 3 Types of ETT. | 10 Participants |
| Teleflex ISIS ETT | Evaluation the Trachea and Vocal Cords at the Time of ETT Extubation to Determine Whether There is a Difference in the Amount of Mucosal Injury Between the 3 Types of ETT. | 11 Participants |
| Standard ETT | Evaluation the Trachea and Vocal Cords at the Time of ETT Extubation to Determine Whether There is a Difference in the Amount of Mucosal Injury Between the 3 Types of ETT. | 7 Participants |
Secondary
the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT
Time to intubate trachea
Time frame: 1 hour
Population: Time to intubate trachea in all groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TaperGuard Evac ETT | the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT | 7.53 minutes | Standard Deviation 0.48 |
| Teleflex ISIS ETT | the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT | 7.59 minutes | Standard Deviation 0.48 |
| Standard ETT | the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT | 7.41 minutes | Standard Deviation 0.58 |