Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications

Study Overview
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Brief Summary
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The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.

Official Title
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Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications: Prospective Randomized Control Trial

Conditions
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Intubation Complication

Intervention / Treatment
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* Device: ventilation with critical intracuff pressure (Pcr)
* Device: ventilation with critical intracuff pressure (Pcr)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective Surgery under general anesthesia requiring endotracheal tube with mechanical ventilation and expected anesthesia duration of at least 2 hours. No contra-indication for intra-operative volume controlled mechanical ventilation Flat supine surgeries without expected positional adjustments American Society of Anesthesiologists (ASA) physical status I-III Exclusion Criteria: Use of Nitrous Oxide BMI > 40 Ventilation through Nasal intubation or Tracheostomy Preexisting sore throat, coughing, nausea/vomiting Recent history of upper respiratory infection Pregnancy Expected to be kept intubated after surgery completion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Device: ventilation with critical intracuff pressure (Pcr)<br>* Once the intra-cuff pressure is measured and recorded, the cuff will be deflated by drawing the air 0.5ml per step with each step lasting 3 breaths until a leak, in which a 10% reduction in expiratory volume over the inspiratory tidal volume, is detected.Cuff will then be reinflated until the expiratory tidal volume reaches the inspiratory tidal volume and the discrepancy between the inspiratory and expiratory tidal volume is less than 10 percent. If the intra-cuff pressure applied by the anesthesia care team is inadequate and the discrepancy between the inspiratory and expiratory tidal volume is 10% or greater, the cuff will be further inflated with air 0.5ml per step with each step lasting 3 breaths until it reaches Pcr. This Pcr will be maintained during the entire anesthesia time until extubation.During the course of surgery, if any leak is detected, the cuff will be re-inflated by 0.5ml of air until the leak is not detectable.<br>|
| Placebo Comparator: Control Group<br> | Device: ventilation with critical intracuff pressure (Pcr)<br>* Pcr is obtained just as it is done in the intervention group. The cuff will then be reinsufflated to the actual cuff pressure the care team initially chose. The care team will be blinded to the measured critical cuff pressures and hence will maintain the usual level of intracuff pressure in the control group during the entire anesthesia time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum intracuff pressure at which there is no air leak around the cuff. |  | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with postoperative sore throat as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 30 minutes post extubation | 
| Number of patients with postoperative sore throat as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 2 hours post extubation | 
| Number of patients with postoperative sore throat as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 24 hours post extubation | 
| Number of patients with postoperative coughing as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 30 minutes post extubation | 
| Number of patients with postoperative coughing as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 2 hours post extubation | 
| Number of patients with postoperative coughing as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 24 hours post extubation | 
| Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 30 minutes post extubation | 
| Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 2 hours post extubation | 
| Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 24 hours post extubation | 
| Number of patients with postoperative aspiration as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 30 minutes post extubation | 
| Number of patients with postoperative aspiration as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 2 hours post extubation | 
| Number of patients with postoperative aspiration as measured by a standardized questionnaire | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe | 24 hours post extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, endotracheal tube cuff pressure