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

January 7, 2018 updated by: Başak Bayram, Dokuz Eylul University

Dokuz Eylul University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 35340
        • Dokuz Eylul University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BPAP ST/T
Non-invasive Ventilation with BPAP ST/T mode
Device: Noninvasive mechanical ventilation
Experimental: AVAPS
Non-invasive Ventilation with AVAPS mode
Device: Noninvasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaCO2 values
Time Frame: On arrival, at one hour, and at two hourly intervals thereafter
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure of treatment options
Time Frame: During the treatment
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
Time Frame: up to 6 months
Length of hospital stay in the hospital (From the emergency department admission)
up to 6 months
The time of treatment
Time Frame: During the treatment
The sum of the noninvasive ventilation time in the emergency department.
During the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Study Director: Başak Bayram, MD, Dokuz Eylul University, School of Medicine, Department of Emergency Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2016

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

January 7, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 7, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2089357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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