Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02538263
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : May 22, 2019
Information provided by (Responsible Party):
Zujin Luo, Beijing Chao Yang Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Hypercapnic Respiratory Failure Device: Volume-targeted noninvasive ventilation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Volume-targeted noninvasive ventilation
For Volume-targeted noninvasive ventilation, the target VT was set at 10 ml/kg of ideal body weight, with inspiratory positive airway pressure (IPAP) ranging from 10 cmH2O up to 25 cmH2O.
Device: Volume-targeted noninvasive ventilation
No Intervention: Pressure-limited noninvasive ventilation
For Pressure-limited noninvasive ventilation, IPAP was initially set at 10 cmH2O, and was adjusted by increments of 1-2 cmH2O according to patients' tolerance (up to 25 cmH2O) to obtain a VT of 8-10 ml/kg of ideal body weight and a respiratory rate (RR) less than 25 breaths/min.

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02538263

Layout table for location information
Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
Beijing, China
Sponsors and Collaborators
Beijing Chao Yang Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Zujin Luo, Attending physician, Beijing Chao Yang Hospital Identifier: NCT02538263    
Other Study ID Numbers: BeijingCYH-ICU-001
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory