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

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Hypercapnic Respiratory Failure

Treatments: Device: Noninvasive mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03398239

2089357

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

BPAP ST/T

Active Comparator group

Description:

Non-invasive Ventilation with BPAP ST/T mode

Treatment:

Device: Noninvasive mechanical ventilation

AVAPS

Experimental group

Description:

Non-invasive Ventilation with AVAPS mode

Treatment:

Device: Noninvasive mechanical ventilation