Evaluation of Above the Cuff Suctioning During General Anesthesia

Study Overview
=================
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: Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port Endotracheal Tube (Teleflex ISIS ETT). Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT). 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.

Official Title
-----------------
Evaluation of Microaspiration and Efficacy of Above the Cuff Suctioning During General Anesthesia: A Comparison of Two Endotracheal Tubes With Suction Above Cuff With a Standard Endotracheal Tube

Conditions
-----------------
Secretion Removal Above ETT Cuff

Intervention / Treatment
-----------------
* Drug: methylene blue


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TaperGuard Evac ETT<br>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 | Drug: methylene blue<br>* 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.<br>* Other names: Urolene Blue;|
| Experimental: Teleflex ISIS ETT<br>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 | Drug: methylene blue<br>* 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.<br>* Other names: Urolene Blue;|
| Active Comparator: Standard ETT<br>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) | Drug: methylene blue<br>* 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.<br>* Other names: Urolene Blue;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suction, aspiration, general anesthesia, intubation, endotracheal tube, respiratory complications