Comparison of BPAP ST/T and BPAP ST / T Mode With AVAPS f... | NCT03398239

Studies
Comparison of BPAP ST/T and BPAP ST / T Mode With AVAPS for Hypercapnic Respiratory Failure in ED

NCT03398239

Sponsor

Dokuz Eylul University

Status

Completed

Last Update Posted

Jan 12, 2018Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Hypercapnic Respiratory Failure

Interventions

Noninvasive mechanical ventilation

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

Jan 2018

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

Oct 20, 2016Actual

Primary Completion Date

Jul 20, 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Nov 30, 2016

First Submission Date that Met QC Criteria

Jan 7, 2018

First Posted Date

Jan 12, 2018Actual

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

Jan 7, 2018

Last Update Posted Date

Jan 12, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Başak Bayram, Assistant Professor Dr., Dokuz Eylul UniversityPrincipal Investigator

Lead Sponsor

Dokuz Eylul UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in hospital.

Detailed Description

Non-invasive positive pressure ventilation (NIMV) is a life-saving procedure for patients with hypoxic and/or hypercapnic respiratory failure. AVAPS (average volume assured pressure support) is a noninvasive ventilation mode which has been developed to assure volume and pressure controlled respiratory support. AVAPS can ensure a constant tidal air volume to the patient with variable pressure support. Thus the positive features of the volume and pressure controlled support, which have a positive impact on the healing and recovery processes are combined.

This study aims to compare, in a randomized order, BPAP ST/T and BPAP ST / T Mode with AVAPS, in patients with hypercapnic respiratory failure in the emergency department.

Subjects: One hundred and two patients with hypercapnic respiratory failure will be included.

Primary outcome; decrease in the PaCO2 values

Secondary outcomes are stated as; Failure of treatment options, or change of the NIMV mode due to patient noncompliance or the patient's need for intubation and length of hospital stay (length of stay in the hospital from the emergency department).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BPAP ST/T	Active Comparator	Non-invasive Ventilation with BPAP ST/T mode	Device: Noninvasive mechanical ventilation
AVAPS	Experimental	Non-invasive Ventilation with AVAPS mode	Device: Noninvasive mechanical ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Noninvasive mechanical ventilation	Device		AVAPS BPAP ST/T

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PaCO2 values	Will measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS	On arrival, at one hour, and at two hourly intervals thereafter

Secondary Outcomes

Measure	Description	Time Frame
Failure of treatment options	Change of the NIMV mode due to patient noncompliance (switching to the second mode) or the patient's need for intubation during the treatment	During the treatment
Length of hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PaCO2 > 45mmHg and any of the following

SaO2 <90% on air
SaO2 <93% on >6 Litres O2/min
Inability to speak in sentences due to respiratory distress
Respiratory rate > 24/min
Altered mental status
The use of accessory muscles of respiration

Exclusion Criteria:

Respiratory arrest or unstable cardiorespiratory status
Suspected Pneumothorax
Urgent need for intubation
Systolic blood pressure < 90 mmHg
Inability to protect airway
Facial deformity
Facial, esophageal, or gastric surgery history
All trauma patients
Acute myocardial infarction
Severe arrythmias
Refractory nausea and vomiting

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Başak Bayram, MD	Dokuz Eylul University, School of Medicine, Department of Emergency Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dokuz Eylul University Hospital		Izmir		35340	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D006935	Hypercapnia

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided