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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. Identifier: NCT03652324
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 31, 2018
Bozok University
Information provided by (Responsible Party):
Gamze Talih, Bozok University

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.

Condition or disease Intervention/treatment Phase
Coil Treatment Deep Sedation Other: method Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of General Anesthesia and Deep Sedation in Enbronchial Coil Treatment
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : August 28, 2018
Actual Study Completion Date : August 28, 2018

Arm Intervention/treatment
randomized Other: method
to compare the use of general anesthesia and deep sedation

Primary Outcome Measures :
  1. recovery time measurement [ Time Frame: 2 hours ]
    to compare the recovery time in both groups

  2. complication rate [ Time Frame: 2 hours ]
    to compare the complication rate in both groups

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients diagnosed with COPD with undergoing BLVR coil treatment.

Exclusion Criteria:

  • patients who refuse to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03652324

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Bozok University
Yozgat, Eyalet/Yerleşke, Turkey, 66100
Sponsors and Collaborators
TC Erciyes University
Bozok University
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Responsible Party: Gamze Talih, Doctor, Bozok University Identifier: NCT03652324    
Other Study ID Numbers: 60174989-23
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamze Talih, Bozok University:
coil treatment
general anesthesia
deep sedation