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The study was terminated because of slower than anticipated enrollment
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| Name | Class |
|---|---|
| Teleflex | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TaperGuard Evac ETT | Experimental | 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 |
|
| Teleflex ISIS ETT | Experimental | 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 |
|
| Standard ETT | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylene blue | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Mraovic, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
We did initial 10 roll-in subjects to be familiar with all of the procedures and recordings.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | number of participants with dye | 4 hours |
|
24 h
Postoperative pulmonary complications (pneumonia, aspiration pneumonitis, atelectasis, pleural effusion or respiratory insufficiency/failure).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| post-operative cough, sputum production or wheezing within 24 hours | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | post-operative cough, sputum production or wheezing within 24 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boris Mraovic | University of Missouri Columbia | 573-882-2568 | mraovicb@health.missouri.edu |
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| ID | Term |
|---|---|
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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|
| the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT | Time to intubate trachea | 1 hour |
| 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 | 4 hours |
| 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. | 4 hours |
| 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. | 4 hours |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| ASA | American Society of Anesthesiology Physical Status: ASA I: A normal healthy patient. ASA II: A patient with mild systemic disease. ASA III: A patient with a severe systemic disease that is not life-threatening | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| 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. | Average Secretion pH | Posted | Mean | Standard Deviation | pH | 4 hours |
|
|
|
| Secondary | the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT | Time to intubate trachea | Time to intubate trachea in all groups | Posted | Mean | Standard Deviation | minutes | 1 hour |
|
|
|
| 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 | Extubation bronchoscopy data. some data are not available in all groups | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| 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. | Total Secretion Volume collected in Luken's trap. NO data for standard groups since there was no suction port in the standard ETT | Posted | Mean | Standard Deviation | mL | 4 hours |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | 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. | 0 | 17 | 1 | 17 |
| EG002 | 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. | 0 | 16 | 1 | 16 |
|
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| II |
|
| III |
|