Differences in endotracheal tube cuff sealing by applying four methods of endotracheal tube cuff inflation in patients undergoing general surgery procedures

Not Applicable

Completed

• Conditions: endotracheal tube cuff sealing; complications from endotracheal cuff tube overinflation; Anaesthesiology - Anaesthetics; Respiratory - Other respiratory disorders / diseases; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12615000699561
• Lead Sponsor: Georgia Tsaousi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-03
• Study Completion: 2016-04-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

Adult patients, ASA physical status 1 to 3, Mallampati score 1-2, oral endotracheal intubation with a high-volume and low-pressure endotracheal tube, N2O free general anesthesia, intraoperative normothermia, conventional mechanical ventilation.

Exclusion Criteria

Tracheostomy, surgical procedures involving the neck or the upper airwa, laryngo-tracheal pathology, history of previous tracheostomy, high-frequency oscillatory ventilation, history of difficult airway management, above 2 intubation attempts and prone positioning.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ETT cuff pressure obtained by each method of cuff inflation.<br>This will be based on the indications obtained by a non-invasive manometer applied in the pilot balloon.[Just after ETT cuff inflation];The air needed for ETT cuff inflation in each method. This will be measured as ml of air used to inflate the cuff with a pre-filled with air 10 ml-syringe.[As soon as ETT cuff inflation is completed]

Secondary Outcome Measures

Name	Time	Method
Presence of complications such as sore throat, that might occur in each method of ETT cuff inflation. This will be based on patient's self-reporting of painful sensation localized to the pharynx or surrounding anatomy.[Two, six and twenty-four hours postoperatively ];Presence of complications such as hoarseness (dysphonia) that might occur in each method of ETT cuff inflation. The patient will be assessed with the GRBAS scale. This is a subjective rating scale providing a measure of the overall grade (G), roughness (R), breathiness (B), asthenia or weakness (A), and strain (S) of dysphonia as judged by the listener on a scale of 0 to 4 (0: normal, 1: mild, 2: moderate, 3: moderate to severe, 4: severe).[Two, six and twenty-four hours postoperatively ];Presence of complications such as dysphagia that might occur in each method of ETT cuff inflation. This will be assessed by Functional Oral Intake Scale numbered as 1 the worse and as 7 the best response.[Two, six and twenty-four hours postoperatively ]