Primary outcomeNumber· 4 hours
Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery
| Group | Value (number of participants with dye) |
|---|---|
| TaperGuard Evac ETT | 0 |
| Teleflex ISIS ETT | 0 |
| Standard ETT | 2 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataEvaluation of Above the Cuff Suctioning During General Anesthesia
NCTNCT01386879 (opens ClinicalTrials.gov in a new tab)Other id11D.48
This trial was stopped early.
Reason given at the registry: The study was terminated because of slower than anticipated enrollment
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 50 participants (actual)
- Sponsor
- Thomas Jefferson University · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- Jul 2011
- Primary completion
- Oct 2012
- Completion
- Oct 2012
- First posted
- 1 Jul 2011 (estimated)
- Last update posted
- 8 Jun 2022
- Conditions
- Secretion Removal Above ETT Cuff
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201120122013
- Ph 4Terminated
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
- methylene blueDrug
Arms3
Experimental
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
Experimental
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
Active comparator
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)
Primary outcomes1
Outcomes the sponsor listed as primary.
Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery
Time frame · 4 hours
Registry description
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 outcomes(5)
Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Time frame · 4 hours
Registry description
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
Time frame · 1 hour
Registry description
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.
Time frame · 4 hours
Registry description
number of patients with mucosal injury and blood below the vocal cords
Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery
Time frame · 4 hours
Registry description
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
Time frame · 4 hours
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeMean· 4 hours
Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery
| Group | Value (pH) | Spread |
|---|---|---|
| TaperGuard Evac ETT | 7.38 | 0.59 |
| Teleflex ISIS ETT | 7.29 | 0.41 |
Secondary outcomeMean· 1 hour
the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT
| Group | Value (minutes) | Spread |
|---|---|---|
| TaperGuard Evac ETT | 7.53 | 0.48 |
| Teleflex ISIS ETT | 7.59 | 0.48 |
| Standard ETT | 7.41 | 0.58 |
Secondary outcomeCount of participants· 4 hours
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.
| Group | Value (Participants) |
|---|---|
| TaperGuard Evac ETT | 10 |
| Teleflex ISIS ETT | 11 |
| Standard ETT | 7 |
Secondary outcomeMean· 4 hours
Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery
| Group | Value (mL) | Spread |
|---|---|---|
| TaperGuard Evac ETT | 13.00 | 10.48 |
| Teleflex ISIS ETT | 26.00 | 19.01 |
Secondary outcomeCount of participants· 4 hours
Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery
| Group | Value (Participants) |
|---|---|
| TaperGuard Evac ETT | 13 |
| Teleflex ISIS ETT | 13 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| TaperGuard Evac ETTTrachea 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. | – | 0 / 17 | 1 / 17 |
| Teleflex ISIS ETTTrachea 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. | – | 0 / 17 | 1 / 17 |
| Standard ETTControl 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. | – | 0 / 16 | 1 / 16 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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)
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