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

NCT ID: NCT03398239

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-20
• Study Completion Date: 2017-08-31

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).

Conditions

Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BPAP ST/T

Non-invasive Ventilation with BPAP ST/T mode

Group Type: ACTIVE_COMPARATOR

Noninvasive mechanical ventilation

Intervention Type: DEVICE

AVAPS

Non-invasive Ventilation with AVAPS mode

Group Type: EXPERIMENTAL

Noninvasive mechanical ventilation

Intervention Type: DEVICE

Interventions

Noninvasive mechanical ventilation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Başak Bayram

Assistant Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Başak Bayram, MD

Role: STUDY_DIRECTOR

Dokuz Eylul University, School of Medicine, Department of Emergency Medicine

Locations

Dokuz Eylul University Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2089357

Identifier Type: -

Identifier Source: org_study_id