Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation

Respiratory Failure Clinical Trial

— FBAIDNIPPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462668
• Other study ID #: LNong
• Status: Completed
• Phase: N/A
• First received: May 24, 2015
• Last updated: August 2, 2017
• Start date: June 2015
• Est. completion date: June 18, 2017

Study information

• Verified date: August 2017
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 18, 2017
• Est. primary completion date: June 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Bag-mask ventilation
The control group receives preoxygenation with bag-mask ventilation
• Noninvasive positive pressure ventilation(NIPPV)
The NIPPV group receives noninvasive positive pressure ventilation during fibreoptic bronchoscopy assisted intubation
• fibreoptic bronchoscopy assisted intubation
All patients will receive fibreoptic bronchoscopy assisted intubation.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Lingbo Nong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	28 days survival rate		From the day of intubation to 28 days
Primary	Change in pulse oxymetry(SpO2)		From time of randomization until connect to ventilator 30min
Secondary	Mechanical ventilation Time		28 days