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

Not Applicable

Completed

• Conditions: Hypercapnic Respiratory Failure
• Interventions: Device: Noninvasive mechanical ventilation

• Registration Number: NCT03398239
• Lead Sponsor: Dokuz Eylul University

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).

Study Timeline

• Study Start: 2016-10-20
• Study First Submitted: 2016-11-30
• Primary Completion: 2017-07-20
• Study Completion: 2017-08
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-07
• Last Update Submitted: 2018-01-07
• Study First Posted: 2018-01-12
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPAP ST/T	Noninvasive mechanical ventilation	Non-invasive Ventilation with BPAP ST/T mode
AVAPS	Noninvasive mechanical ventilation	Non-invasive Ventilation with AVAPS mode

Primary Outcome Measures

Name	Time	Method
PaCO2 values	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

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 6 months	Length of hospital stay in the hospital (From the emergency department admission)
Failure of treatment options	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
The time of treatment	During the treatment	The sum of the noninvasive ventilation time in the emergency department.

Trial Locations

Locations (1)

Dokuz Eylul University Hospital; 🇹🇷 Izmir, Turkey