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

Primary Purpose

Acute Hypercapnic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Volume-targeted noninvasive ventilation
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Volume-targeted noninvasive ventilation

Pressure-limited noninvasive ventilation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The decrease of arterial partial pressure of carbon dioxide (PaCO2) values from baseline to 6 hours after randomization
PaCO2 value at baseline minus PaCO2 value at 6 hours after randomization

Secondary Outcome Measures

Full Information

First Posted
August 27, 2015
Last Updated
May 21, 2019
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02538263
Brief Title
Volume-targeted Versus Pressure-limited Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypercapnic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volume-targeted noninvasive ventilation
Arm Type
Experimental
Arm Description
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.
Arm Title
Pressure-limited noninvasive ventilation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Volume-targeted noninvasive ventilation
Primary Outcome Measure Information:
Title
The decrease of arterial partial pressure of carbon dioxide (PaCO2) values from baseline to 6 hours after randomization
Description
PaCO2 value at baseline minus PaCO2 value at 6 hours after randomization
Time Frame
6 hours after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27794079
Citation
Cao Z, Luo Z, Hou A, Nie Q, Xie B, An X, Wan Z, Ye X, Xu Y, Chen X, Zhang H, Xu Z, Wang J, An F, Li P, Yu C, Liang Y, Zhang Y, Ma Y. Volume-Targeted Versus Pressure-Limited Noninvasive Ventilation in Subjects With Acute Hypercapnic Respiratory Failure: A Multicenter Randomized Controlled Trial. Respir Care. 2016 Nov;61(11):1440-1450. doi: 10.4187/respcare.04619. Epub 2016 Oct 18.
Results Reference
derived

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

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