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

Not Applicable

Completed

• Conditions: Acute Hypercapnic Respiratory Failure
• Interventions: Device: Volume-targeted noninvasive ventilation

• Registration Number: NCT02538263
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-29
• Study First Posted: 2015-09-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volume-targeted noninvasive ventilation	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

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