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

Dokuz Eylul University80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypercapnic Respiratory Failure

Interventions

Noninvasive mechanical ventilationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dokuz Eylul University Hospital

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: On arrival, at one hour, and at two hourly intervals thereafter

Secondary Outcomes

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

Time frame: During the treatment

Length of hospital stay

Length of hospital stay in the hospital (From the emergency department admission)

Time frame: up to 6 months

The time of treatment

The sum of the noninvasive ventilation time in the emergency department.

Time frame: During the treatment

Data from ClinicalTrials.gov

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