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Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

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ClinicalTrials.gov Identifier: NCT02214368
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Zhou Yongfang, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Other: Early application of NIV Device: Fiberoptic bronchoscopy Drug: Propofol Other: Conventional application of NIV Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Noninvasive Ventilation Bundle in Postoperative Respiratory Failure
Study Start Date : January 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: NIV bundle group
early use of NIV, and combination fiberoptic bronchoscopy and sedation
Other: Early application of NIV

Device:BiPAP Vision.

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

Other Name: Early application of BiPAP Vision (Respironics)

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 Name: Diprivan

Conventional treatment group
standard supplemental oxygen, and conventional application of noninvasive ventilation.
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.
Other Name: Conventional application of BiPAP Vision (Respironics)




Primary Outcome Measures :
  1. the need of endotracheal intubation [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214368


Locations
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China, Sichuan
Department of Critical care medicine of West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Y F Zhou, MM Department of critical care medicine of West China Hospital

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Responsible Party: Zhou Yongfang, Master of medicine, West China Hospital
ClinicalTrials.gov Identifier: NCT02214368    
Other Study ID Numbers: YB20130097
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics