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Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

Primary Purpose

Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early application of NIV
Fiberoptic bronchoscopy
Propofol
Conventional application of NIV
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Critical care medicine of West China Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NIV bundle group

Conventional treatment group

Arm Description

early use of NIV, and combination fiberoptic bronchoscopy and sedation

standard supplemental oxygen, and conventional application of noninvasive ventilation.

Outcomes

Primary Outcome Measures

the need of endotracheal intubation

Secondary Outcome Measures

Full Information

First Posted
August 5, 2014
Last Updated
August 15, 2015
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02214368
Brief Title
Noninvasive Ventilation Bundle in Postoperative Respiratory Failure
Official Title
The Efficacy and Safety of Noninvasive Ventilation Bundle in Postoperative Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIV bundle group
Arm Type
Experimental
Arm Description
early use of NIV, and combination fiberoptic bronchoscopy and sedation
Arm Title
Conventional treatment group
Arm Type
Other
Arm Description
standard supplemental oxygen, and conventional application of noninvasive ventilation.
Intervention Type
Other
Intervention Name(s)
Early application of NIV
Other Intervention Name(s)
Early application of BiPAP Vision (Respironics)
Intervention Description
Device:BiPAP Vision. NIV bundle group : Early application of NIV(BiPAP Vision) in 1 h after randomization.
Intervention Type
Device
Intervention Name(s)
Fiberoptic bronchoscopy
Intervention Description
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
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
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
Other
Intervention Name(s)
Conventional application of NIV
Other Intervention Name(s)
Conventional application of BiPAP Vision (Respironics)
Intervention Description
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.
Primary Outcome Measure Information:
Title
the need of endotracheal intubation
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Y F Zhou, MM
Organizational Affiliation
Department of critical care medicine of West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Critical care medicine of West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

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Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

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