Clinical trial NCT02462668: Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation
Official title: The Efficiency and Safety of Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: Bronchoscopy
Intubation
Noninvasive positive pressure ventilation
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pulse oxymetry(SpO2)
timeFrame: From time of randomization until connect to ventilator 30min
Secondary outcomes:
measure: Mechanical ventilation Time
timeFrame: 28 days
Other outcomes:
measure: 28 days survival rate
timeFrame: From the day of intubation to 28 days
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Hospital Of Guangzhou Medical college
name: Rongchang Chen, investigator
role: STUDY_DIRECTOR
References:
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.