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

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Capital Medical University

Status

Completed

Conditions

Acute Hypercapnic Respiratory Failure

Treatments

Device: Volume-targeted noninvasive ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT02538263
BeijingCYH-ICU-001

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 2 patient groups

Volume-targeted noninvasive ventilation
Experimental group
Description:
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.
Treatment:
Device: Volume-targeted noninvasive ventilation
Pressure-limited noninvasive ventilation
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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