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

NCT ID: NCT02538263

Last Updated: 2019-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Acute Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Volume-targeted noninvasive ventilation

Intervention Type: DEVICE

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Volume-targeted noninvasive ventilation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zujin Luo

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 27794079 (View on PubMed)

Other Identifiers

BeijingCYH-ICU-001

Identifier Type: -

Identifier Source: org_study_id