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

The Efficiency and Safety of Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation

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 ).

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: Bag-mask ventilation; Procedure: fibreoptic bronchoscopy assisted intubation; Procedure: Noninvasive positive pressure ventilation(NIPPV)

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Preoxygenation with Bag-mask ventilation before fibreoptic bronchoscopy assisted intubation. Intervention: Bag-mask ventilation.	Procedure: Bag-mask ventilation; The control group receives preoxygenation with bag-mask ventilation; Procedure: fibreoptic bronchoscopy assisted intubation; All patients will receive 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: fibreoptic bronchoscopy assisted intubation; All patients will receive fibreoptic bronchoscopy assisted intubation.; Procedure: Noninvasive positive pressure ventilation(NIPPV); The NIPPV group receives noninvasive positive pressure ventilation during fibreoptic bronchoscopy assisted intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in pulse oxymetry(SpO2)	From time of randomization until connect to ventilator 30min

Secondary Outcome Measures

Outcome Measure	Time Frame
Mechanical ventilation Time	28 days

Other Outcome Measures

Outcome Measure	Time Frame
28 days survival rate	From the day of intubation to 28 days

Collaborators and Investigators

• Sponsor: Lingbo Nong
• Investigators: Study Director: Rongchang Chen, investigator, The First Hospital Of Guangzhou Medical college

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): June 11, 2017
• Study Completion (Actual): June 18, 2017

Study Registration Dates

• First Submitted: May 24, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Bronchoscopy; Noninvasive positive pressure ventilation; Intubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: LNong