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NCT02538263 Clinical Trial

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

Acute Hypercapnic Respiratory Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02538263
Other study ID # BeijingCYH-ICU-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date December 2013

Study information
Verified date May 2019
Source Beijing Chao Yang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Volume-targeted noninvasive ventilation

Locations
Country Name City State
China Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 hours after randomization
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