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What Should be the Anesthesia Method in Endobronchial Coil Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652324
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Bozok University
Information provided by (Responsible Party):
Gamze Talih, Bozok University

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE March 28, 2018
Actual Primary Completion Date August 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • recovery time measurement [ Time Frame: 2 hours ]
    to compare the recovery time in both groups
  • complication rate [ Time Frame: 2 hours ]
    to compare the complication rate in both groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE What Should be the Anesthesia Method in Endobronchial Coil Treatment
Official Title  ICMJE Comparison of General Anesthesia and Deep Sedation in Enbronchial Coil Treatment
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coil Treatment
  • Deep Sedation
Intervention  ICMJE Other: method
to compare the use of general anesthesia and deep sedation
Study Arms  ICMJE randomized
Intervention: Other: method
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 28, 2018
Actual Primary Completion Date August 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients diagnosed with COPD with undergoing BLVR coil treatment.

Exclusion Criteria:

  • patients who refuse to participate in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03652324
Other Study ID Numbers  ICMJE 60174989-23
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gamze Talih, Bozok University
Study Sponsor  ICMJE TC Erciyes University
Collaborators  ICMJE Bozok University
Investigators  ICMJE Not Provided
PRS Account TC Erciyes University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP