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Clinical Trials/NCT00925613
NCT00925613CompletedPhase 3

Exchange of a Double Lumen Tube With a Proseal Laryngeal Mask or Single Lumen Endotracheal Tube Before Emergence Following a Thoracic Surgery: a Randomized-controlled Trial.

Université de Montréal1 site in 1 country60 target enrollmentStarted: April 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Frequency of cough

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Frequency of cough

Time Frame: From change to supine position to 10 minutes after removal of airway device

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Issam Tanoubi

Université de Montréal

Université de Montréal

Study Sites (1)

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