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

This study has been completed.
Sponsor:
Collaborator:
Maisonneuve-Rosemont Hospital
Information provided by (Responsible Party):
Issam Tanoubi, Université de Montréal
ClinicalTrials.gov Identifier:
NCT00925613
First received: June 19, 2009
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Cough
Laryngospasm
Apnea
Desaturation
Voice Hoarseness
Device: LMA Proseal
Device: Tracheal tube
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Frequency of cough [ Time Frame: From change to supine position to 10 minutes after removal of airway device ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
The double lumen tube is kept until extubation; there is no exchange with any tracheal tube or LMA.
Active Comparator: Proseal
The double lumen tube is exchanged with a Proseal (LMA) before emergence according to the study protocol.
Device: LMA Proseal

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.

Other Name: Proseal, laryngeal mask airways
Active Comparator: Tracheal tube
The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol.
Device: Tracheal tube
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.
Other Name: Single lumen endotracheal tube

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925613

Locations
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
Université de Montréal
Maisonneuve-Rosemont Hospital
Investigators
Study Chair: François Donati, PhD MD FRCPC Université de Montréal
Study Director: Issam Tanoubi, MD Université de Montréal
Principal Investigator: Joanna Ng Man Sun, MD Université de Montréal
  More Information

No publications provided

Responsible Party: Issam Tanoubi, Université de Montréal
ClinicalTrials.gov Identifier: NCT00925613     History of Changes
Other Study ID Numbers: Proseal08083
Study First Received: June 19, 2009
Last Updated: April 21, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Université de Montréal:
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

Additional relevant MeSH terms:
Apnea
Cough
Hoarseness
Laryngismus
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Voice Disorders
Laryngeal Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on July 10, 2014