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

NCT00925613 | Completed Phase 3 DMC

• 1 other identifier: Proseal08083
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Frequency of cough

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

Study Arms (3)

Control

NO INTERVENTION

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

Proseal

ACTIVE COMPARATOR

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

Device: LMA Proseal

Tracheal tube

ACTIVE COMPARATOR

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

Device: Tracheal tube

Interventions

LMA Proseal DEVICE

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.

Also known as: Proseal, laryngeal mask airways

Proseal

Tracheal tube DEVICE

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.

Also known as: Single lumen endotracheal tube

Tracheal tube

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old undergoing elective thoracic surgery
• intubation with double lumen tube required
• patients in category ASA 1, 2, 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Montréal: lead
• Maisonneuve-Rosemont Hospital: collaborator

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 25985845 DERIVED

MeSH Terms

Conditions

Cough; Laryngismus; Apnea; Hoarseness

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vocal Cord Dysfunction; Laryngeal Diseases; Otorhinolaryngologic Diseases; Voice Disorders; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• François Donati, PhD MD FRCPC

  Université de Montréal

  STUDY CHAIR

• Issam Tanoubi, MD

  Université de Montréal

  STUDY DIRECTOR

• Joanna Ng Man Sun, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Université de Montréal

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 22, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

CA (1)