Benefits of Exchanging a Double Lumen Tube to a Proseal Laryngeal Mask or a Single Lumen Tube After a Thoracic Surgery
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
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Cough Laryngospasm Apnea Desaturation Voice Hoarseness |
Device: LMA Proseal Device: Tracheal tube |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| 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. |
- Frequency of cough [ Time Frame: From change to supine position to 10 minutes after removal of airway device ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
The double lumen tube is kept until extubation; there is no exchange with any tracheal tube or LMA.
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Active Comparator: Proseal
The double lumen tube is exchanged with a Proseal (LMA) before emergence according to the study protocol.
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Device: 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. Other Name: Proseal, laryngeal mask airways
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Active Comparator: Tracheal tube
The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol.
|
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.
Other Name: Single lumen endotracheal tube
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Joanna Ng Man Sun, MD | 514-825-5971 | joanna.nms@gmail.com |
| Contact: Issam Tanoubi, MD | 514-252-3808 | itanoubi@gmail.com |
| Canada, Quebec | |
| Maisonneuve-Rosemont Hospital | Recruiting |
| Montreal, Quebec, Canada | |
| Contact: Joanna Ng Man Sun, MD 514-825-5971 joanna.nms@gmail.com | |
| Contact: Issam Tanoubi, MD 514-252-3808 itanoubi@gmail.com | |
| Study Chair: | François Donati, PhD MD FRCPC | Université de Montréal |
| Study Director: | Issam Tanoubi, MD | Université de Montréal |
| Principal Investigator: | Joanna Ng Man Sun, MD | Université de Montréal |
More Information
No publications provided
| Responsible Party: | Joanna Ng Man Sun / Anesthesiology resident, University of Montreal |
| ClinicalTrials.gov Identifier: | NCT00925613 History of Changes |
| Other Study ID Numbers: | Proseal08083 |
| Study First Received: | June 19, 2009 |
| Last Updated: | June 19, 2009 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Université de Montréal:
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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 |
Additional relevant MeSH terms:
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Apnea Cough Hoarseness Laryngismus Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Voice Disorders Laryngeal Diseases Otorhinolaryngologic Diseases Neurologic Manifestations Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013