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Completed

NCT Number: NCT03398239

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

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.

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Key information

Conditions

Hypercapnic Respiratory Failure Hypercapnia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University Hospital

Izmir, 35340, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

noninvasive mechanical ventilation

Device

Primary outcomes

  1. PaCO2 values

    Time frame: On arrival, at one hour, and at two hourly intervals thereafter

    Will measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS

Secondary outcomes

  1. Failure of treatment options

    Time frame: During the treatment

    Change of the NIMV mode due to patient noncompliance (switching to the second mode) or the patient's need for intubation during the treatment

  2. Length of hospital stay

    Time frame: up to 6 months

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

  3. The time of treatment

    Time frame: During the treatment

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

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

Dokuz Eylul University School of Medicine

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2018
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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