Clinical trial NCT03398239: Comparison of BPAP ST/T and BPAP ST / T Mode With AVAPS for Hypercapnic Respiratory Failure in ED
Official title: Dokuz Eylul University School of Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnic Respiratory Failure
Keywords: respiratory failure, hypercapnia, BPAP, AVAPS
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: PaCO2 values
timeFrame: On arrival, at one hour, and at two hourly intervals thereafter
Secondary outcomes:
measure: Failure of treatment options
timeFrame: During the treatment
measure: Length of hospital stay
timeFrame: up to 6 months
measure: The time of treatment
timeFrame: During the treatment
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital
Study officials:
affiliation: Dokuz Eylul University, School of Medicine, Department of Emergency Medicine
name: Başak Bayram, MD
role: STUDY_DIRECTOR
References: