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NCT Number: NCT02538263

Volume-targeted Versus Pressure-limited Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure

Volume-targeted noninvasive ventilation (VT-NIV), a hybrid mode that targets a preseted tidal volume (VT) by automated adjustment of pressure support, could guarantee the delivered VT over pressure-limited noninvasive ventilation (PL-NIV) with fixed level pressure support. Whether VT-NIV is more effective in improving gas exchange in patients with acute hypercapnic respiratory failure (AHRF) as compared with PL-NIV remains unclear. Our aim was to verify whether in comparison with PL-NIV, use of VT-NIV was more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in patients with AHRF.

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Key information

Conditions

Acute Hypercapnic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • acute hypercapnic respiratory failure (AHRF)
  • arterial pH <7.35 and ≥7.25
  • PaCO2 >45 mmHg

Exclusion criteria

  • age <18 years
  • excessive amount of respiratory secretions or weak cough
  • upper airway obstruction
  • recent oral, facial or cranial trauma or surgery
  • recent gastric or esophageal surgery
  • severe metabolic acidosis; severe abdominal distension
  • cardiac or respiratory arrest
  • PaO2/FiO2 <150 mmHg
  • pneumothorax
  • severe ventricular arrhythmia or myocardial ischemia
  • severe hemodynamic instability despite fluid repletion and use of vasoactive agents
  • active upper gastrointestinal bleeding
  • lack of cooperation
  • refusal to receive NIV

Treatment and study plan

Volume-targeted noninvasive ventilation

Device

Primary outcomes

  1. The decrease of arterial partial pressure of carbon dioxide (PaCO2) values from baseline to 6 hours after randomization

    Time frame: 6 hours after randomization

    PaCO2 value at baseline minus PaCO2 value at 6 hours after randomization

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 2, 2015
Registry last updated
May 22, 2019

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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