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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Cough, Laryngospasm, Apnea, Desaturation, Voice Hoarseness

Intervention / Treatment
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* Device: LMA Proseal
* Device: Tracheal tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The double lumen tube is kept until extubation; there is no exchange with any tracheal tube or LMA. | |
| Active Comparator: Proseal<br>The double lumen tube is exchanged with a Proseal (LMA) before emergence according to the study protocol. | Device: LMA Proseal<br>* 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.<br>* Other names: Proseal, laryngeal mask airways;|
| Active Comparator: Tracheal tube<br>The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol. | Device: Tracheal tube<br>* 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.<br>* Other names: Single lumen endotracheal tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cough |  | From change to supine position to 10 minutes after removal of airway device | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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