What Should be the Anesthesia Method in Endobronchial Coil Treatment

Deep Sedation Clinical Trial

Official title:

Comparison of General Anesthesia and Deep Sedation in Enbronchial Coil Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652324
• Other study ID #: 60174989-23
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: August 2018
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients diagnosed with COPD with undergoing BLVR coil treatment.

Exclusion Criteria:

• patients who refuse to participate in the study

Related Conditions & MeSH terms

• Coil Treatment
• Deep Sedation

Intervention

Other:
• method
to compare the use of general anesthesia and deep sedation

Locations

Country	Name	City	State
Turkey	Bozok University	Yozgat	Eyalet/Yerleske

Sponsors (2)

Lead Sponsor	Collaborator
TC Erciyes University	Bozok University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recovery time measurement	to compare the recovery time in both groups	2 hours
Primary	complication rate	to compare the complication rate in both groups	2 hours