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

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ClinicalTrials.gov Identifier: NCT02538263
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Zujin Luo, Beijing Chao Yang Hospital

Study Description
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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

Study Design
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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

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Arms and Interventions
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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.


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02538263


Locations
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China
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zujin Luo, Attending physician, Beijing Chao Yang Hospital
ClinicalTrials.gov 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:
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Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory