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

NCT ID: NCT00925613

Last Updated: 2014-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-12-31

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.

Conditions

Cough; Laryngospasm; Apnea; Desaturation; Voice Hoarseness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Proseal

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

Group Type: ACTIVE_COMPARATOR

LMA Proseal

Intervention Type: 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.

Tracheal tube

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

Group Type: ACTIVE_COMPARATOR

Tracheal tube

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Proseal, laryngeal mask airways; Single lumen endotracheal tube

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Issam Tanoubi

Université de Montréal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

François Donati, PhD MD FRCPC

Role: STUDY_CHAIR

Université de Montréal

Issam Tanoubi, MD

Role: STUDY_DIRECTOR

Université de Montréal

Joanna Ng Man Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25985845 (View on PubMed)

Other Identifiers

Proseal08083

Identifier Type: -

Identifier Source: org_study_id