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Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation (FBAIDNIPPV)

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bag-mask ventilation
Noninvasive positive pressure ventilation(NIPPV)
fibreoptic bronchoscopy assisted intubation
Sponsored by
Lingbo Nong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Bronchoscopy, Intubation, Noninvasive positive pressure ventilation

Eligibility Criteria

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

Inclusion Criteria:

  • Acute respiratory failure requiring intubation,
  • Age greater than or equal to 18 years

Exclusion Criteria:

  1. Nasal polyps，Nasopharyngeal cancer，Nasal bleeding，Rhinitis，Sinusitis and so on Nasal disease
  2. Basal skull fracture
  3. Severe coagulopathy, blood platelet counts <50×10*9/L
  4. Nose and facial deformities, trauma
  5. Cardiac arrest
  6. Pregnancy or puerpera

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

NIPPV

Arm Description

Preoxygenation with Bag-mask ventilation before fibreoptic bronchoscopy assisted intubation. Intervention: Bag-mask ventilation.

The NIPPV group preoxygenation with noninvasive positive pressure ventilation(NIPPV), And then receives fibreoptic bronchoscopy intubation through a face mask (there is a small hole allow to insert the tracheal tube through the mask into trachea) during NIPPV. Intervention: noninvasive positive pressure ventilation(NIPPV)

Outcomes

Primary Outcome Measures

Change in pulse oxymetry(SpO2)

Secondary Outcome Measures

Mechanical ventilation Time

Full Information

First Posted
May 24, 2015
Last Updated
August 2, 2017
Sponsor
Lingbo Nong
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1. Study Identification

Unique Protocol Identification Number
NCT02462668
Brief Title
Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation
Acronym
FBAIDNIPPV
Official Title
The Efficiency and Safety of Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 11, 2017 (Actual)
Study Completion Date
June 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lingbo Nong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted intubation during noninvasive positive pressure ventilation in respiratory failure patients. Half of the participants will receive preoxygenation with noninvasive ventilator and fibreoptic bronchoscopy intubation during NIPPV. While the other half using usual preoxygenation(bag-mask ventilation ).
Detailed Description
Respiratory failure is very common for critically ill patients, Main complication associated with intubation was desaturation. Usual preoxygenation( bag-mask ventilation) have been show that marginally effective in critically ill patients. As a result, there is a need to optimize the technique of preoxygenation to prolong the safe duration of apnea during the intubation procedure in critically ill patients. Noninvasive ventilation provides continuous positive airway pressure is effective in increasing the efficiency of gas exchange and in reducing the decrease in oxyhemoglobin saturation during fiberoptic bronchoscopy in hypoxemic patients. Therefore, our aim was to study whether NIPPV is more effective at reducing desaturation than usual preoxygenation in hypoxemic, critically ill patients requiring intubation in ICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Bronchoscopy, Intubation, Noninvasive positive pressure ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Preoxygenation with Bag-mask ventilation before fibreoptic bronchoscopy assisted intubation. Intervention: Bag-mask ventilation.
Arm Title
NIPPV
Arm Type
Experimental
Arm Description
The NIPPV group preoxygenation with noninvasive positive pressure ventilation(NIPPV), And then receives fibreoptic bronchoscopy intubation through a face mask (there is a small hole allow to insert the tracheal tube through the mask into trachea) during NIPPV. Intervention: noninvasive positive pressure ventilation(NIPPV)
Intervention Type
Procedure
Intervention Name(s)
Bag-mask ventilation
Intervention Description
The control group receives preoxygenation with bag-mask ventilation
Intervention Type
Procedure
Intervention Name(s)
Noninvasive positive pressure ventilation(NIPPV)
Intervention Description
The NIPPV group receives noninvasive positive pressure ventilation during fibreoptic bronchoscopy assisted intubation
Intervention Type
Procedure
Intervention Name(s)
fibreoptic bronchoscopy assisted intubation
Intervention Description
All patients will receive fibreoptic bronchoscopy assisted intubation.
Primary Outcome Measure Information:
Title
Change in pulse oxymetry(SpO2)
Time Frame
From time of randomization until connect to ventilator 30min
Secondary Outcome Measure Information:
Title
Mechanical ventilation Time
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
28 days survival rate
Time Frame
From the day of intubation to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute respiratory failure requiring intubation, Age greater than or equal to 18 years Exclusion Criteria: Nasal polyps，Nasopharyngeal cancer，Nasal bleeding，Rhinitis，Sinusitis and so on Nasal disease Basal skull fracture Severe coagulopathy, blood platelet counts <50×10*9/L Nose and facial deformities, trauma Cardiac arrest Pregnancy or puerpera
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen, investigator
Organizational Affiliation
The First Hospital Of Guangzhou Medical college
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31785505
Citation
Nong L, Liang W, Yu Y, Xi Y, Liu D, Zhang J, Zhou J, Yang C, He W, Liu X, Li Y, Chen R. Noninvasive ventilation support during fiberoptic bronchoscopy-guided nasotracheal intubation effectively prevents severe hypoxemia. J Crit Care. 2020 Apr;56:12-17. doi: 10.1016/j.jcrc.2019.10.017. Epub 2019 Nov 14.
Results Reference
derived

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Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation

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