- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03652324
What Should be the Anesthesia Method in Endobronchial Coil Treatment
August 29, 2018 updated by: Gamze Talih, TC Erciyes University
Comparison of General Anesthesia and Deep Sedation in Enbronchial Coil Treatment
This prospective, randomize study was conducted in a university hospital.
Bronchoscopic lung volume reduction (BLVR) coil treatment has recently been introduced into clinical practice as an alternative for patients chronic obstructive pulmonary disease (COPD) with severe refractory heterorogenous emphysema to conventional medical treatment.
Thirty two patients diagnosed with (COPD) with severe refractory heterorogenous emphysema undergoing BLVR coil treatment were included in the study.
Seventeen procedure were performed under general anesthesia and fifteen procedure were performed under deep sedation-analgesia. in the general anesthesia group peak pressure, air leakage and end-tidal carbon dioxide were recorded.
In the both groups pulse oximeter, transcutaneous carbondioxide, recovery time, bronchospasm, laryngospasm, pneumothorax, massive bleeding were recorded.
Study Overview
Study Type
Interventional
Enrollment (Actual)
32
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
-
-
Eyalet/Yerleşke
-
Yozgat, Eyalet/Yerleşke, Turkey, 66100
- Bozok University
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients diagnosed with COPD with undergoing BLVR coil treatment.
Exclusion Criteria:
- patients who refuse to participate in the study
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: randomized
|
to compare the use of general anesthesia and deep sedation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recovery time measurement
Time Frame: 2 hours
|
to compare the recovery time in both groups
|
2 hours
|
complication rate
Time Frame: 2 hours
|
to compare the complication rate in both groups
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 28, 2018
Primary Completion (Actual)
August 28, 2018
Study Completion (Actual)
August 28, 2018
Study Registration Dates
First Submitted
August 28, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 29, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 60174989-23
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.
Clinical Trials on Deep Sedation
-
I.M. Sechenov First Moscow State Medical UniversityCompleted
-
Karolinska University HospitalCompleted
-
Hospital Universitari de BellvitgeUnknown
-
University Hospital Inselspital, BerneGE HealthcareCompletedCritical Care | Conscious Sedation | Deep SedationSwitzerland
-
University Medical Center GroningenNot yet recruiting
-
First Affiliated Hospital Xi'an Jiaotong UniversityNot yet recruiting
-
Bambino Gesù Hospital and Research InstituteCompleted
-
Cedars-Sinai Medical CenterCompletedAnesthesia | Deep SedationUnited States
-
Peking UniversityCompletedDexmedetomidine | Deep SedationChina
Clinical Trials on method
-
University of North Carolina, Chapel HillWithdrawn
-
Istanbul UniversityRecruitingAmelogenesis Imperfecta | Dental Age EstimationTurkey
-
Firat UniversityNot yet recruitingPain | Child Development | Nursing CareTurkey
-
Dr. Behcet Uz Children's HospitalRecruitingAcute Respiratory Distress Syndrome | Acute Respiratory Failure | Pediatric Acute Respiratory Distress Syndrome (PARDS)Turkey
-
Indonesia UniversityCompletedPremature | Feeding; Difficult, NewbornIndonesia
-
Assistance Publique - Hôpitaux de ParisURC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital; EA 7334...Unknown
-
JSI Research & Training Institute, Inc.UnknownWasting | Severe Acute Malnutrition
-
Centre Hospitalier Universitaire DijonUnknownElderly People | Food Intake MeasurementFrance
-
University of LiegeUniversite du Quebec en OutaouaisCompletedVoice Disorders | Virtual Reality TherapyBelgium
-
University of MalayaCompleted