Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Procedure: Noninvasive positive pressure ventilation(NIPPV); Procedure: Bag-mask ventilation; Procedure: fibreoptic bronchoscopy assisted intubation

• Registration Number: NCT02462668
• Lead Sponsor: Lingbo Nong

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.

Study Timeline

• Study First Submitted: 2015-05-24
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Primary Completion: 2017-06-11
• Study Completion: 2017-06-18
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	fibreoptic bronchoscopy assisted intubation	Preoxygenation with Bag-mask ventilation before fibreoptic bronchoscopy assisted intubation. Intervention: Bag-mask ventilation.
NIPPV	Noninvasive positive pressure ventilation(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)
Control	Bag-mask ventilation	Preoxygenation with Bag-mask ventilation before fibreoptic bronchoscopy assisted intubation. Intervention: Bag-mask ventilation.
NIPPV	fibreoptic bronchoscopy assisted intubation	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)

Primary Outcome Measures

Name	Time	Method
Change in pulse oxymetry(SpO2)	From time of randomization until connect to ventilator 30min

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation Time	28 days

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China