Clinical trial NCT00925613: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Maisonneuve-Rosemont Hospital
First posted: 2009-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Frequency of cough
timeFrame: From change to supine position to 10 minutes after removal of airway device
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Université de Montréal
name: François Donati, PhD MD FRCPC
role: STUDY_CHAIR
affiliation: Université de Montréal
name: Issam Tanoubi, MD
role: STUDY_DIRECTOR
affiliation: Université de Montréal
name: Joanna Ng Man Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.