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CompletedNCT02462668FBAIDNIPPVUpdated Aug 4, 2017

Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation

An interventional study of Bag-mask ventilation and Noninvasive positive pressure ventilation(NIPPV) in Respiratory Failure, sponsored by Lingbo Nong. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by Lingbo Nong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 ).

Read the 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.

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Conditions studied

  • Respiratory Failure

Keywords

  • Bronchoscopy
  • Intubation
  • Noninvasive positive pressure ventilation
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 106 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

This is the only study on the registry with Lingbo Nong as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
106 participants (actual)

Study arms

  • Placebo comparator
    Control

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

    Procedure: Bag-mask ventilation · Procedure: fibreoptic bronchoscopy assisted intubation

  • Experimental
    NIPPV

    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)

    Procedure: Noninvasive positive pressure ventilation(NIPPV) · Procedure: fibreoptic bronchoscopy assisted intubation

Interventions

  • ProcedureBag-mask ventilation

    The control group receives preoxygenation with bag-mask ventilation

  • ProcedureNoninvasive positive pressure ventilation(NIPPV)

    The NIPPV group receives noninvasive positive pressure ventilation during fibreoptic bronchoscopy assisted intubation

  • Procedurefibreoptic bronchoscopy assisted intubation

    All patients will receive fibreoptic bronchoscopy assisted intubation.

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What researchers measure

Primary outcomes

  1. Change in pulse oxymetry(SpO2)

    Time frame: From time of randomization until connect to ventilator 30min

Secondary outcomes

  1. Mechanical ventilation Time

    Time frame: 28 days

Other outcomes

  1. 28 days survival rate

    Time frame: From the day of intubation to 28 days

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Study locations

1 site
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
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References and documents

Publications

  • 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. PubMed 31785505 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02462668
Lead sponsor
Lingbo Nong
Responsible party
Lingbo Nong (MD, The First Affiliated Hospital of Guangzhou Medical University) — Sponsor-investigator
First posted
Jun 4, 2015
Start date
Jun 2015
Primary completion
Jun 11, 2017
Completion
Jun 18, 2017
Last update
Aug 4, 2017

Study contacts

Rongchang Chen, investigator
study director · The First Hospital Of Guangzhou Medical college

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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