Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation

NCT02462668 | Completed DMC

• 1 other identifier: LNong
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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 ).

Conditions

Respiratory Failure

Keywords

Bronchoscopy; Intubation; Noninvasive positive pressure ventilation

Outcome Measures

Primary Outcomes (1)

• Change in pulse oxymetry(SpO2)

  From time of randomization until connect to ventilator 30min

Secondary Outcomes (1)

• Mechanical ventilation Time

  28 days

Other Outcomes (1)

• 28 days survival rate

  From the day of intubation to 28 days

Study Arms (2)

Control

PLACEBO COMPARATOR

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

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

NIPPV

EXPERIMENTAL

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

Bag-mask ventilation PROCEDURE

The control group receives preoxygenation with bag-mask ventilation

Control

Noninvasive positive pressure ventilation(NIPPV) PROCEDURE

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

NIPPV

fibreoptic bronchoscopy assisted intubation PROCEDURE

All patients will receive fibreoptic bronchoscopy assisted intubation.

Control; NIPPV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lingbo Nong: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• 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.

  PMID: 31785505 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Rongchang Chen, investigator

  The First Hospital Of Guangzhou Medical college

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 24, 2015
• First Posted: June 4, 2015
• Study Start: June 1, 2015
• Primary Completion: June 11, 2017
• Study Completion: June 18, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

CN (1)