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
About this trial
This is an interventional treatment trial for Hypercapnic Respiratory Failure focused on measuring respiratory failure, hypercapnia, BPAP, AVAPS
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
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
NCT ID
NCT03398239
First Posted
November 30, 2016
Last Updated
January 7, 2018
Sponsor
Dokuz Eylul University
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
Learn more about this trial
Comparison of BPAP ST/T and BPAP ST / T Mode With AVAPS for Hypercapnic Respiratory Failure in ED
We'll reach out to this number within 24 hrs