NCT03652324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

August 28, 2018

Last Update Submit

August 29, 2018

Conditions

Coil TreatmentDeep Sedation

Keywords

coil treatmentgeneral anesthesiadeep sedation

Outcome Measures

Primary Outcomes (2)

  • recovery time measurement

    to compare the recovery time in both groups

    2 hours

  • complication rate

    to compare the complication rate in both groups

    2 hours

Study Arms (1)

randomized

OTHER
Other: method

Interventions

methodOTHER

to compare the use of general anesthesia and deep sedation

randomized

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed with COPD with undergoing BLVR coil treatment.

You may not qualify if:

  • patients who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bozok University

Yozgat, Eyalet/Yerleşke, 66100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 29, 2018

Study Start

March 28, 2018

Primary Completion

August 28, 2018

Study Completion

August 28, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

TU(1)