ClinicalTrials.gg
CompletedNCT03398239Updated Jan 12, 2018

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

An interventional study of Noninvasive mechanical ventilation in Hypercapnic Respiratory Failure, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-12.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Hypercapnic Respiratory Failure

Keywords

  • respiratory failure, hypercapnia, BPAP, AVAPS
03

In context

Respiratory Insufficiency

1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • nausea and vomiting
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    BPAP ST/T

    Non-invasive Ventilation with BPAP ST/T mode

    Device: Noninvasive mechanical ventilation

  • Experimental
    AVAPS

    Non-invasive Ventilation with AVAPS mode

    Device: Noninvasive mechanical ventilation

Interventions

  • DeviceNoninvasive mechanical ventilation
06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Length of hospital stay

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

    Time frame: up to 6 months

  3. The time of treatment

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

    Time frame: During the treatment

07

Study locations

1 site
  • Dokuz Eylul University Hospital
    Izmir, 35340, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03398239
Responsible party
Başak Bayram (Assistant Professor Dr., Dokuz Eylul University) — Principal investigator
First posted
Jan 12, 2018
Start date
Oct 20, 2016
Primary completion
Jul 20, 2017
Completion
Aug 2017
Last update
Jan 12, 2018

Study contacts

Başak Bayram, MD
study director · Dokuz Eylul University, School of Medicine, Department of Emergency Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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