Trial Outcomes & Findings for Evaluation of Above the Cuff Suctioning During General Anesthesia (NCT NCT01386879)
NCT ID: NCT01386879
Last Updated: 2022-06-08
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
4 hours
Results posted on
2022-06-08
Participant Flow
We did initial 10 roll-in subjects to be familiar with all of the procedures and recordings.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
16
|
|
Overall Study
COMPLETED
|
17
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TaperGuard Evac ETT
n=17 Participants
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.
|
Teleflex ISIS ETT
n=17 Participants
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.
|
Standard ETT
n=16 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.88 years
STANDARD_DEVIATION 8.62 • n=17 Participants
|
55.53 years
STANDARD_DEVIATION 15.00 • n=17 Participants
|
54.56 years
STANDARD_DEVIATION 12.85 • n=16 Participants
|
54.66 years
STANDARD_DEVIATION 12.15 • n=50 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=17 Participants
|
7 Participants
n=17 Participants
|
8 Participants
n=16 Participants
|
22 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=17 Participants
|
10 Participants
n=17 Participants
|
8 Participants
n=16 Participants
|
28 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
28.40 kg/m^2
STANDARD_DEVIATION 3.25 • n=17 Participants
|
26.23 kg/m^2
STANDARD_DEVIATION 4.12 • n=17 Participants
|
26.85 kg/m^2
STANDARD_DEVIATION 4.41 • n=16 Participants
|
27.16 kg/m^2
STANDARD_DEVIATION 3.92 • n=50 Participants
|
|
ASA
I
|
0 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=16 Participants
|
4 Participants
n=50 Participants
|
|
ASA
II
|
12 Participants
n=17 Participants
|
9 Participants
n=17 Participants
|
8 Participants
n=16 Participants
|
29 Participants
n=50 Participants
|
|
ASA
III
|
5 Participants
n=17 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=16 Participants
|
17 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: 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.
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.
Outcome measures
| Measure |
TaperGuard Evac ETT
n=16 Participants
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.
|
Teleflex ISIS ETT
n=17 Participants
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.
|
Standard ETT
n=16 Participants
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.
|
|---|---|---|---|
|
Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery
|
0 number of participants with dye
|
0 number of participants with dye
|
2 number of participants with dye
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Average Secretion pH
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.
Outcome measures
| Measure |
TaperGuard Evac ETT
n=17 Participants
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.
|
Teleflex ISIS ETT
n=17 Participants
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.
|
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.
|
|---|---|---|---|
|
Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery
|
7.38 pH
Standard Deviation 0.59
|
7.29 pH
Standard Deviation 0.41
|
—
|
SECONDARY outcome
Timeframe: 1 hourPopulation: Time to intubate trachea in all groups
Time to intubate trachea
Outcome measures
| Measure |
TaperGuard Evac ETT
n=17 Participants
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.
|
Teleflex ISIS ETT
n=17 Participants
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.
|
Standard ETT
n=16 Participants
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.
|
|---|---|---|---|
|
the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT
|
7.53 minutes
Standard Deviation 0.48
|
7.59 minutes
Standard Deviation 0.48
|
7.41 minutes
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Extubation bronchoscopy data. some data are not available in all groups
number of patients with mucosal injury and blood below the vocal cords
Outcome measures
| Measure |
TaperGuard Evac ETT
n=13 Participants
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.
|
Teleflex ISIS ETT
n=16 Participants
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.
|
Standard ETT
n=14 Participants
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.
|
|---|---|---|---|
|
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
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Total Secretion Volume collected in Luken's trap. NO data for standard groups since there was no suction port in the standard ETT
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.
Outcome measures
| Measure |
TaperGuard Evac ETT
n=17 Participants
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.
|
Teleflex ISIS ETT
n=17 Participants
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.
|
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.
|
|---|---|---|---|
|
Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery
|
13.00 mL
Standard Deviation 10.48
|
26.00 mL
Standard Deviation 19.01
|
—
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: 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.
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.
Outcome measures
| Measure |
TaperGuard Evac ETT
n=17 Participants
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.
|
Teleflex ISIS ETT
n=17 Participants
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.
|
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.
|
|---|---|---|---|
|
Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery
|
13 Participants
|
13 Participants
|
—
|
Adverse Events
TaperGuard Evac ETT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Teleflex ISIS ETT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard ETT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TaperGuard Evac ETT
n=17 participants at risk
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.
|
Teleflex ISIS ETT
n=17 participants at risk
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.
|
Standard ETT
n=16 participants at risk
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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
post-operative cough, sputum production or wheezing within 24 hours
|
5.9%
1/17 • Number of events 1 • 24 h
Postoperative pulmonary complications (pneumonia, aspiration pneumonitis, atelectasis, pleural effusion or respiratory insufficiency/failure).
|
5.9%
1/17 • Number of events 1 • 24 h
Postoperative pulmonary complications (pneumonia, aspiration pneumonitis, atelectasis, pleural effusion or respiratory insufficiency/failure).
|
6.2%
1/16 • Number of events 1 • 24 h
Postoperative pulmonary complications (pneumonia, aspiration pneumonitis, atelectasis, pleural effusion or respiratory insufficiency/failure).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place