NCT02214368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

August 5, 2014

Last Update Submit

August 15, 2015

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

  • the need of endotracheal intubation

    7 days

Study Arms (2)

NIV bundle group

EXPERIMENTAL

early use of NIV, and combination fiberoptic bronchoscopy and sedation

Other: Early application of NIVDevice: Fiberoptic bronchoscopyDrug: Propofol

Conventional treatment group

OTHER

standard supplemental oxygen, and conventional application of noninvasive ventilation.

Other: Conventional application of NIV

Interventions

Early application of NIVOTHER

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

Also known as: Early application of BiPAP Vision (Respironics)
NIV bundle group
Fiberoptic bronchoscopyDEVICE

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.

NIV bundle group
PropofolDRUG

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.

Also known as: Diprivan
NIV bundle group
Conventional application of NIVOTHER

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.

Also known as: Conventional application of BiPAP Vision (Respironics)
Conventional treatment group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Propofol

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Y F Zhou, MM

    Department of critical care medicine of West China Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of medicine

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 12, 2014

Study Start

January 1, 2013

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

CN(1)