Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

Study Overview
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Brief Summary
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The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.

Official Title
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Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

Conditions
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Endotracheal Tube

Intervention / Treatment
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* Procedure: MOVT
* Procedure: VE/VI ratio of Spirometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status I, II Body mass index < 30 kg/m2 Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position Exclusion Criteria: History of airway-related or pulmonary diseases/abnormalities When difficult intubation is anticipated History of general anesthesia within the past 3 months Pregnancy History of smoking

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two methods of cuff sealing will be applied in a random sequence to each patient.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cuff sealing by MOVT<br>MOVT (minimal occlusive volume technique). The cuff sealing will be confirmed with MOVT, then the intracuff pressure will be measured. | Procedure: MOVT<br>* ETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.<br>|
| Active Comparator: Cuff sealing by VE/VI ratio<br>VE/VI ratio of Spirometer. The cuff sealing will be confirmed with VE/VI ratio of a spirometer, then the intracuff pressure will be measured. | Procedure: VE/VI ratio of Spirometer<br>* ETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracuff Pressure | The intracuff pressure of endotracheal tube when cuff sealing is achieved. | From the start of cuff inflation to the airway sealing, an average of 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracuff air volume | The intracuff air volume of endotracheal tube when cuff sealing is achieved. | From the start of cuff inflation to the airway sealing, an average of 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spirometer, Endotracheal tube, Intracuff pressure, Minimal occlusive volume technique, Endotracheal sealing