Benefits of Exchanging a Double Lumen Tube to a Proseal Laryngeal Mask or a Single Lumen Tube After a Thoracic Surgery

Phase 3

Completed

• Conditions: Laryngospasm; Cough; Apnea; Desaturation; Voice Hoarseness
• Interventions: Device: LMA Proseal; Device: Tracheal tube

• Registration Number: NCT00925613
• Lead Sponsor: Université de Montréal

Brief Summary

The purpose of this study is to determine whether exchange of the double lumen tube before emergence with a laryngeal mask airway (Proseal) or a tracheal tube will reduce cough at emergence.

Detailed Description

Intubation with a double lumen tube is often the preferred method to ensure isolation of the lung and proper exposition of the surgical site during thoracoscopies and thoracostomies. Unfortunately, because of the length and diameter of the double lumen tube, it is known to cause more irritation in the upper airways thereby inducing cough at emergence. In turn, cough has been associated with numerous multisystemic complications. Severe respiratory complications include laryngospasm or upper airway obstruction, desaturation, vocal cord injury, tracheal and bronchial ruptures. The purpose of this study is to determine whether exchange of the double lumen tube before emergence with a laryngeal mask airway (Proseal) or a tracheal tube will reduce cough at emergence.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Primary Completion: 2010-08
• Study Completion: 2010-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-21
• Last Update Posted: 2014-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-75 year old undergoing elective thoracic surgery
• intubation with double lumen tube required
• patients in category ASA 1, 2, 3

Exclusion Criteria

• Difficult intubation anticipated
• Presence of gastro-esophageal reflux
• Patients considered with a full stomach
• Body mass index >30
• Presence of nasogastric tube when exchange should be done
• Patients undergoing oesophagogastrectomy
• Allergy to any medication used in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proseal	LMA Proseal	The double lumen tube is exchanged with a Proseal (LMA) before emergence according to the study protocol.
Tracheal tube	Tracheal tube	The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol.

Primary Outcome Measures

Name	Time	Method
Frequency of cough	From change to supine position to 10 minutes after removal of airway device

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada