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

NCT02538263 | Completed

• 1 other identifier: BeijingCYH-ICU-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Volume-targeted noninvasive ventilation

EXPERIMENTAL

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.

Device: Volume-targeted noninvasive ventilation

Pressure-limited noninvasive ventilation

NO INTERVENTION

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.

Interventions

Volume-targeted noninvasive ventilation DEVICE

Volume-targeted noninvasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute hypercapnic respiratory failure (AHRF)
• arterial pH \<7.35 and ≥7.25
• PaCO2 \>45 mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

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

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 27794079 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 2, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

CN (1)