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

Dokuz Eylul University School of Medicine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03398239
Enrollment
80
Registered
2018-01-12
Start date
2016-10-20
Completion date
2017-08-31
Last updated
2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnic Respiratory Failure

Keywords

respiratory failure, hypercapnia, BPAP, AVAPS

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).

Interventions

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PaCO2 valuesOn arrival, at one hour, and at two hourly intervals thereafterWill measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS

Secondary

MeasureTime frameDescription
Failure of treatment optionsDuring the treatmentChange of the NIMV mode due to patient noncompliance (switching to the second mode) or the patient's need for intubation during the treatment
Length of hospital stayup to 6 monthsLength of hospital stay in the hospital (From the emergency department admission)
The time of treatmentDuring the treatmentThe sum of the noninvasive ventilation time in the emergency department.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026