Nasal Ventilation vs Face Mask

Not Applicable

• Conditions: Nasotracheal Intubation
• Interventions: Procedure: nasal ventilation crossover face mask ventilation; Procedure: face mask ventilation crossover nasal ventilation

• Registration Number: NCT03853239
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

Nasotracheal intubation(NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck. While these patients showed higher rates of difficult laryngoscopy. Therefore, duration of apnoea is prolonged and re-oxygenation is inevitable.Mask ventilation is the most fundamental technique in maintaining oxygenation, even when endotracheal intubation is failed. However, the most common complication of NTI is epistaxis, removing the nasotracheal tube could make mask ventilation extremely difficult.So the investigatorsbelieve the ideal approach is ventilation through original nasotracheal tube.Several techniques of supraglottic ventilations through endotracheal tubes have been reported.It remains uncertain whether supraglottic ventilation through inflated nasal RAE endotracheal tube has similar efficiency as mask ventilation after general anesthesia induction. Based on previous clinical experience, the investigators hypothesised that ventilations through inflated nasal RAE endotracheal tube and through facemask were comparable in terms of tidal volume and airway pressure in anesthetized, apnoeic adults.

Forty patients were randomly assigned (sealed envelope method) to face mask（Group A，n=20）or nasal ventilation(Group B，n=20), For A: face mask ventilation followed by nasal ventilation and for B:nasal ventilation followed by face mask ventilation.Measure the tidal volume and air leakage of face mask and nasal ventilation during pressure-controlled ventilation mode and volume-controlled mode, respectively.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-22
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Status Verified: 2019-03
• Study Start: 2019-03-01
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age between 18-55 years old
• ASA physical status I and II
• Requiring general anesthesia with nasal intubation

Exclusion Criteria

• Respiratory disease，cardiovascular disease, cerebral vascular disease
• Anticipated Difficult Mask Ventilation(Age>55 years old, obesity,bearded,edentulous,a history of snoring)
• The need for emergency surgery
• Contraindications to nasal intubation
• Pregnancy
• Gastric-esophageal reflex or a full stomach

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nasal ventilation crossover face mask	nasal ventilation crossover face mask ventilation	-
face mask crossover nasal ventilation	face mask ventilation crossover nasal ventilation	-

Primary Outcome Measures

Name	Time	Method
Difference in expired tidal volume of each technique under pressure-controlled mode	3 breaths of expired tidal volume for each technique
Difference in air leakage of each technique under volume-controlled mode	3 breaths of air leakage for each technique

Secondary Outcome Measures

Name	Time	Method
number of participants with Oxygen Saturation- Reading Below 95%	intraoperative duration of each ventilation technique
hemodynamic changes	intraoperative duration of each ventilation technique
peak inspiratory pressure	intraoperative duration of each ventilation technique
end tidal CO2 partial pressure Reading- Median	intraoperative duration of each ventilation technique

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China