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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Dokuz Eylul University School of Medicine

Conditions
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Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: Noninvasive mechanical ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | Length of hospital stay in the hospital (From the emergency department admission) | up to 6 months | 
| The time of treatment | The sum of the noninvasive ventilation time in the emergency department. | During the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory failure, hypercapnia, BPAP, AVAPS