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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:
ClinicalTrials.gov Identifier:
NCT00925613
First Posted: June 22, 2009
Last Update Posted: April 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Maisonneuve-Rosemont Hospital
Information provided by (Responsible Party):
Issam Tanoubi, Université de Montréal
June 19, 2009
June 22, 2009
April 22, 2014
April 2009
August 2010   (Final data collection date for primary outcome measure)
Frequency of cough [ Time Frame: From change to supine position to 10 minutes after removal of airway device ]
Same as current
Complete list of historical versions of study NCT00925613 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Benefits of Exchanging a Double Lumen Tube to a Proseal Laryngeal Mask or a Single Lumen Tube After a Thoracic Surgery
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.
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
  • Cough
  • Laryngospasm
  • Apnea
  • Desaturation
  • Voice Hoarseness
  • 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
  • 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
  • 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.
    Intervention: Device: LMA Proseal
  • Active Comparator: Tracheal tube
    The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol.
    Intervention: Device: Tracheal tube
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00925613
Proseal08083
Yes
Not Provided
Not Provided
Issam Tanoubi, Université de Montréal
Université de Montréal
Maisonneuve-Rosemont Hospital
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
Université de Montréal
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP