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

Primary Purpose

Hypercapnic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Noninvasive mechanical ventilation
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercapnic Respiratory Failure focused on measuring respiratory failure, hypercapnia, BPAP, AVAPS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BPAP ST/T

AVAPS

Arm Description

Non-invasive Ventilation with BPAP ST/T mode

Non-invasive Ventilation with AVAPS mode

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Length of hospital stay
Length of hospital stay in the hospital (From the emergency department admission)
The time of treatment
The sum of the noninvasive ventilation time in the emergency department.

Full Information

First Posted
November 30, 2016
Last Updated
January 7, 2018
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03398239
Brief Title
Comparison of BPAP ST/T and BPAP ST / T Mode With AVAPS for Hypercapnic Respiratory Failure in ED
Official Title
Dokuz Eylul University School of Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure
Keywords
respiratory failure, hypercapnia, BPAP, AVAPS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BPAP ST/T
Arm Type
Active Comparator
Arm Description
Non-invasive Ventilation with BPAP ST/T mode
Arm Title
AVAPS
Arm Type
Experimental
Arm Description
Non-invasive Ventilation with AVAPS mode
Intervention Type
Device
Intervention Name(s)
Noninvasive mechanical ventilation
Primary Outcome Measure Information:
Title
PaCO2 values
Description
Will measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS
Time Frame
On arrival, at one hour, and at two hourly intervals thereafter
Secondary Outcome Measure Information:
Title
Failure of treatment options
Description
Change of the NIMV mode due to patient noncompliance (switching to the second mode) or the patient's need for intubation during the treatment
Time Frame
During the treatment
Title
Length of hospital stay
Description
Length of hospital stay in the hospital (From the emergency department admission)
Time Frame
up to 6 months
Title
The time of treatment
Description
The sum of the noninvasive ventilation time in the emergency department.
Time Frame
During the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Başak Bayram, MD
Organizational Affiliation
Dokuz Eylul University, School of Medicine, Department of Emergency Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylul University Hospital
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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