- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00969683
Double-Lumen Tube With or Without a Carinal Hook
Comparison Between Left Double-lumen Tube With or Without a Carinal Hook During Lung Surgery
Most teams use a left double-lumen tube. The double-lumen tube is available with or without a carinal hook. The hook is supposed to facilitate the positioning of the tube and avoid the mobilization of the tube during surgery. The use of double-lumen tubes with a hook is large in Europe and quite unknown in US. The literature is poor, containing only few case reports.
The purpose of this research is to compare the two types of left double-lumen tube.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Suresnes, France, 92150
- Service d'Anesthésie, Hôpital Foch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients scheduled for lung surgery requiring one-lung ventilation
Exclusion Criteria:
- pregnancy
- ASA class 4
- prevision of difficult intubation or of pulmonary aspiration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Double lumen tube without a hook
Broncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex
|
Tracheal intubation using a Double lumen tube without a hook
Tracheal intubation with a Double lumen tube with a hook
|
Experimental: Double lumen tube with a hook
Broncho-Cath™, Mallinckrodt France, Parc d'Affaires Technopolis, 3 avenue du Canada, Bât Sigma, Les Ulis, 91975 Courtaboeuf Cedex
|
Tracheal intubation using a Double lumen tube without a hook
Tracheal intubation with a Double lumen tube with a hook
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time required to initially position the assigned tube
Time Frame: end of anesthesia
|
end of anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
degree of lung collapse
Time Frame: end of anesthesia
|
end of anesthesia
|
number of intraoperatively FOB examinations
Time Frame: end of anesthesia
|
end of anesthesia
|
Glottic or tracheo-bronchial lesion
Time Frame: end of hospitalisation
|
end of hospitalisation
|
Sore throat or hoarse voice
Time Frame: end of hospitalisation
|
end of hospitalisation
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- 2009/21
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.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
University of ChicagoRecruitingAnesthesia | Patient Satisfaction | Anesthesia Risks | Anesthesia Consent | Consent RetentionUnited States
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMNot yet recruitingPrediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population (CME)Anesthesia, Local | AnesthesiaFrance
-
Matthew BorzageRecruitingAnesthesia | Anesthesia; ReactionUnited States
Clinical Trials on Tracheal intubation
-
University of MalayaCompletedBed up Head Elevated Intubation PositionMalaysia
-
Konya Meram State HospitalNot yet recruiting
-
Mongi Slim HospitalCompletedPostoperative Pain | Anesthesia | Tracheal Intubation Morbidity | Sore-throatTunisia
-
University of Lausanne HospitalsCompletedNasal Obstruction | Lumbar Stenosis, FamilialSwitzerland
-
Patan Academy of Health SciencesNot yet recruitingTo Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy
-
Mansoura UniversityCompletedTechniques of Endotracheal Intubation in PediatricsEgypt
-
Rigshospitalet, DenmarkAmbu A/SUnknownGeneral AnesthesiaDenmark, France
-
Suez Canal UniversityRecruiting
-
Yuzuncu Yıl UniversityCompleted
-
Second Military Medical UniversityCompletedTracheal Intubation MorbidityChina