NCT02214368

Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

The Efficacy and Safety of Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The investigators assessed the efficacy and safety of this noninvasive Ventilation (NIV) bundle strategy compared with a conventional treatment in postoperative patients with ARF.

Detailed description

This is a randomized, prospective, open-label study. Postoperative patients with ARF included in the study were randomly assigned to intervention group or conventional treatment group. In the intervention group, NIV was early used for treatment of postoperative respiratory failure, if patients were inability to spontaneously clear airways from excessive secretions during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions , if patients showed intolerance or inadequate patient cooperation during the NIV session, they were sedated (Ramsay scale 2-3) by a continuous perfusion of propofol during the NIV session. Patients assigned to the control group received supplemental oxygen, Respiratory therapists delivered this intervention using conventional masks or venturi oxygen, and adjusted FiO2 to achieve arterial O2 saturation of more than 92%. The application of noninvasive ventilation was considered, if patients failed the supplemental oxygen and met at least two of the following criteria:(1) severe respiratory distress with dyspnoea, respiratory rate\>30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing, or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less than 60 mm Hg at an FiO2\> 0.5 or breathing at least 10 l/min oxygen. All the patients were continuous monitored of vital signs.whereas arterial blood gases were analyzed before NIV and 1h after NIV, before and after FBO, and once a day and in the case of any change either in the ventilatory settings or in the FIO2; duration of noninvasive ventilation, the rate and cause of endotracheal intubation, ICU and hospital mortality and length of stay in the ICU and in hospital, study procedure related complications.

Conditions

• Respiratory Insufficiency

Interventions

Type	Name	Description
OTHER	Early application of NIV	Device:BiPAP Vision. NIV bundle group : Early application of NIV(BiPAP Vision) in 1 h after randomization.
DEVICE	Fiberoptic bronchoscopy	Device:fiberoptic bronchoscopy. NIV bundle group :When patients were inability to spontaneously clear airways from excessive secretions during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions.
DRUG	Propofol	Drug:propofol.continuous perfusion of propofol (0.50-2.00 mg/kg/h). NIV bundle group :When patients showed intolerance or inadequate patient cooperation during the NIV session, they were sedated (Ramsay scale 2-3) by a continuous perfusion of propofol (0.50-2.00 mg/kg/h). In the conventional treatment group: No intervention.
OTHER	Conventional application of NIV	Conventional treatment group:NIV(BiPAP Vision) was used, when patients failed the supplemental oxygen and met at least two of the following criteria:(1) severe respiratory distress with dyspnoea, respiratory rate\>30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing, or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less than 60 mm Hg at an FiO2\> 0.5 or breathing at least 10 L/min oxygen.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2014-08-12
• Last updated: 2015-08-18

Locations

1 site across 1 country: China