Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

NCT ID: NCT02214368

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-11-30

Brief 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

Study Design

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

Study Groups

NIV bundle group

early use of NIV, and combination fiberoptic bronchoscopy and sedation

Group Type: EXPERIMENTAL

Early application of NIV

Intervention Type: OTHER

Device:BiPAP Vision.

NIV bundle group : Early application of NIV(BiPAP Vision) in 1 h after randomization.

Fiberoptic bronchoscopy

Intervention Type: DEVICE

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.

Propofol

Intervention Type: DRUG

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.

Conventional treatment group

standard supplemental oxygen, and conventional application of noninvasive ventilation.

Group Type: OTHER

Conventional application of NIV

Intervention Type: OTHER

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.

Interventions

Early application of NIV

Device:BiPAP Vision.

NIV bundle group : Early application of NIV(BiPAP Vision) in 1 h after randomization.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Early application of BiPAP Vision (Respironics); Diprivan; Conventional application of BiPAP Vision (Respironics)

Eligibility Criteria

Inclusion Criteria

• Postoperative patients with acute respiratory failure (ARF) were included in the study,who had to meet one of the following criteria
• Respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more)
• Partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 250
• Dyspnoea with respiratory rate > 25 breaths/min or use of accessory respiratory muscles or paradoxical abdominal breathing

Exclusion Criteria

• Cardiac or respiratory arrest; loss of consciousness
• Facial trauma or surgery or deformity sufficient to preclude mask fitting
• Active upper gastrointestinal bleeding
• Haemodynamic instability or unstable cardiac arrhythmia
• Multiple organ failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Yongfang

Master of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Y F Zhou, MM

Role: PRINCIPAL_INVESTIGATOR

Department of critical care medicine of West China Hospital

Locations

Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

YB20130097

Identifier Type: -

Identifier Source: org_study_id