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

Université de Montréal

Status and phase: Completed; Phase 3

Conditions: Apnea; Voice Hoarseness; Cough; Desaturation; Laryngospasm

Treatments: Device: Tracheal tube; Device: LMA Proseal

Study type: Interventional

Funder types: Other

Identifiers

NCT00925613

Proseal08083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Control

No Intervention group

Description:

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

Proseal

Active Comparator group

Description:

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

Treatment:

Device: LMA Proseal

Tracheal tube

Active Comparator group

Description:

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

Treatment:

Device: Tracheal tube