search
Back to results

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

Primary Purpose

Cough, Laryngospasm, Apnea

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
LMA Proseal
Tracheal tube
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cough focused on measuring Exchanging double lumen tube with laryngeal mask Proseal, Exchange double lumen tube with tracheal tube, Exchange double lumen tube before emergence decrease cough, thoracoscopy and postoperative respiratory complications, thoracostomy and postoperative respiratory complications, postoperative cough, postoperative respiratory complications, laryngeal mask and postoperative respiratory complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Proseal

Tracheal tube

Arm Description

The double lumen tube is kept until extubation; there is no exchange with any tracheal tube or LMA.

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

The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol.

Outcomes

Primary Outcome Measures

Frequency of cough

Secondary Outcome Measures

Full Information

First Posted
June 19, 2009
Last Updated
April 21, 2014
Sponsor
Université de Montréal
Collaborators
Maisonneuve-Rosemont Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00925613
Brief Title
Benefits of Exchanging a Double Lumen Tube to a Proseal Laryngeal Mask or a Single Lumen Tube After a Thoracic Surgery
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Laryngospasm, Apnea, Desaturation, Voice Hoarseness
Keywords
Exchanging double lumen tube with laryngeal mask Proseal, Exchange double lumen tube with tracheal tube, Exchange double lumen tube before emergence decrease cough, thoracoscopy and postoperative respiratory complications, thoracostomy and postoperative respiratory complications, postoperative cough, postoperative respiratory complications, laryngeal mask and postoperative respiratory complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The double lumen tube is kept until extubation; there is no exchange with any tracheal tube or LMA.
Arm Title
Proseal
Arm Type
Active Comparator
Arm Description
The double lumen tube is exchanged with a Proseal (LMA) before emergence according to the study protocol.
Arm Title
Tracheal tube
Arm Type
Active Comparator
Arm Description
The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol.
Intervention Type
Device
Intervention Name(s)
LMA Proseal
Other Intervention Name(s)
Proseal, laryngeal mask airways
Intervention Description
Once surgery is completed, the patient is transferred onto a gurney. Train of four is checked. Patient is ventilated with 100% oxygen. Remifentanil 0.5 ug/ml IV is administered. 30 seconds to 1 minute later, secretions are suctioned. Depth of anesthesia is ensured by deflating, inflating, then deflating the tracheal balloon of the DLT and checking for absence of movement, swallowing, or coughing. The DLT is removed, then the LMA proseal is inserted. Respiratory and hemodynamics parameters are noted. Tolerance of the exchange (presence of cough, movement, laryngospasm, desaturation) is noted. Inhalational gas is stopped. Reversal agent is administered if appropriate. Spontaneous breathing is titrated for <12 with boluses of fentanyl 25ug or sufentanil 2.5ug q 5mins. If failure to insert Proseal occurs, a second attempt is made after deepening anesthesia with propofol 1mg/kg and remifentanil 0.5ug/kg IV. If failure occurs again, the patient is intubated with a tracheal tube.
Intervention Type
Device
Intervention Name(s)
Tracheal tube
Other Intervention Name(s)
Single lumen endotracheal tube
Intervention Description
Once surgery is completed, the patient is transferred onto a gurney. Train of four is checked. Patient is ventilated with 100% oxygen. Remifentanil 0.5 ug/ml IV is administered. 30 seconds to 1 minute later, secretions are suctioned. Depth of anesthesia is ensured by deflating, inflating, then deflating the tracheal balloon of the DLT and checking for absence of movement, swallowing, or coughing. The DLT is removed, then a tracheal tube (size 7 for women, size 8 for men) is inserted. Respiratory and hemodynamics parameters are noted. Tolerance of the exchange (presence of cough, movement, laryngospasm, desaturation) is noted. Inhalational gas is stopped. Reversal agent is administered if appropriate. Spontaneous breathing is titrated for <12 with boluses of fentanyl 25ug or sufentanil 2.5ug q 5mins.
Primary Outcome Measure Information:
Title
Frequency of cough
Time Frame
From change to supine position to 10 minutes after removal of airway device

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Donati, PhD MD FRCPC
Organizational Affiliation
Université de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Issam Tanoubi, MD
Organizational Affiliation
Université de Montréal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joanna Ng Man Sun, MD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25985845
Citation
Tanoubi I, Sun JN, Drolet P, Fortier LP, Donati F. Replacing a double-lumen tube with a single-lumen tube or a laryngeal mask airway device to reduce coughing at emergence after thoracic surgery: a randomized controlled single-blind trial. Can J Anaesth. 2015 Sep;62(9):988-95. doi: 10.1007/s12630-015-0403-2. Epub 2015 May 19.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs