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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02538263
Enrollment
58
Registered
2015-09-02
Start date
2013-01-31
Completion date
2013-12-31
Last updated
2019-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypercapnic Respiratory Failure

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.

Interventions

DEVICEVolume-targeted noninvasive ventilation

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The decrease of arterial partial pressure of carbon dioxide (PaCO2) values from baseline to 6 hours after randomization6 hours after randomizationPaCO2 value at baseline minus PaCO2 value at 6 hours after randomization

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026