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

Hypercapnic Respiratory Failure Clinical Trial

Official title:

Dokuz Eylul University School of Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398239
• Other study ID #: 2089357
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: January 7, 2018
• Start date: October 20, 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Noninvasive mechanical ventilation

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	On arrival, at one hour, and at two hourly intervals thereafter
Secondary	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	During the treatment
Secondary	Length of hospital stay	Length of hospital stay in the hospital (From the emergency department admission)	up to 6 months
Secondary	The time of treatment	The sum of the noninvasive ventilation time in the emergency department.	During the treatment