- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00925613
Benefits of Exchanging a Double Lumen Tube to a Proseal Laryngeal Mask or a Single Lumen Tube After a Thoracic Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
Quebec
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Montreal, Quebec, Canada
- Maisonneuve-Rosemont Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
ACTIVE_COMPARATOR: Tracheal tube
The double lumen tube is exchanged with a tracheal tube before emergence according to the study protocol.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of cough
Time Frame: From change to supine position to 10 minutes after removal of airway device
|
From change to supine position to 10 minutes after removal of airway device
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: François Donati, PhD MD FRCPC, Université de Montréal
- Principal Investigator: Joanna Ng Man Sun, MD, Université de Montréal
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- postoperative cough
- 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 respiratory complications
- laryngeal mask and postoperative respiratory complications
Additional Relevant MeSH Terms
Other Study ID Numbers
- Proseal08083
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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