EzPAP Therapy Versus Non-invasive Ventilation Therapy | NCT06663462

Studies
EzPAP Therapy Versus Non-invasive Ventilation Therapy

NCT06663462

Sponsor

Kırklareli University

Status

Completed

Last Update Posted

Oct 29, 2024Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Non Invasive Ventilation

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Jun 30, 2024Actual

First Submitted Date

Oct 19, 2024

First Submission Date that Met QC Criteria

Oct 28, 2024

First Posted Date

Oct 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2024

Last Update Posted Date

Oct 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study compared EzPAP and noninvasive treatments of hypercapnic COPD attacks.

Detailed Description

In this study, the effectiveness of NIV and EzPAP treatments was compared in patients admitted to the emergency department due to hypercapnic COPD exacerbation. Blood gas was taken at the 4th and 24th hours of treatment to evaluate the effectiveness.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EzPAP group		EzPAP users
Non-invasive group		BPAP users

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood gas	Carbon dioxide height, low bicarbonate and presence acidosis measure in the blood gas	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Chronic obstructive pulmonary disease Dyspnea

Exclusion Criteria:

Cardiac failure Dead

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

COPD disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gökhan Karakurt, MD	Kırklareli Training and Research Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oya Guven, MD		Kırklareli	Center	39000	Turkey (Türkiye)