- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05791045
Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation
March 17, 2023 updated by: ILKE KUPELI, Biruni University
Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation Study in Endoscopic Thoracic Sympathetic Blockade
In this trial, we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade.
Study Overview
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34250
- Ilke Kupeli
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 135 patients underwent bilateral ETSB procedure under general anesthesia
Exclusion Criteria:
- patients who underwent one sided ETSB
- patients under the age of 18
- Patients over 65 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: double lumen tube
In the DLT group, the lung on the side to be treated was distinguished from the ventilator and extinguished and single lung ventilation was performed with the other lung.
|
we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade
|
Active Comparator: single lumen tube
In the SLT group, after thoracoscopic input, the anesthetist was in contact with the surgeon and his lung pressures were reduced manually until the lowest pressure, where the surgeon's vision was optimal.
|
we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anesthesia time
Time Frame: 1 year
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anesthesia time during intubation
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hashmonai M, Kopelman D. History of sympathetic surgery. Clin Auton Res. 2003 Dec;13 Suppl 1:I6-9. doi: 10.1007/s10286-003-1103-5.
- Caso R, Kelly CH, Marshall MB. Single lumen endotracheal intubation with carbon dioxide insufflation for lung isolation in thoracic surgery. Surg Endosc. 2019 Oct;33(10):3287-3290. doi: 10.1007/s00464-018-06614-9. Epub 2018 Dec 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
March 17, 2023
First Submitted That Met QC Criteria
March 17, 2023
First Posted (Actual)
March 30, 2023
Study Record Updates
Last Update Posted (Actual)
March 30, 2023
Last Update Submitted That Met QC Criteria
March 17, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Biruni HLM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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