Nasal Ventilation vs Face Mask

Nasotracheal Intubation Clinical Trial

Official title:

A Randomised, Crossover Comparison of Nasal Ventilation vs Face Mask in Anesthetised Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03853239
• Other study ID #: nasal ventilation vs face mask
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: March 2019
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Yu Sun, MD,PhD
• Phone: 0086-136-1189-5542
• Email: dr_sunyu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasotracheal Intubation

Intervention

Procedure:
• face mask ventilation crossover nasal ventilation
Group A was first ventilated through the face mask, and the tidal volume was measured under pressure-controlled mode (10, 15, 20 cm H2O) ;Switched to volume-controlled (6,8,10ml/kg predicted body weight)mode, the actual tidal volume was recorded, and the air leakage was calculated. Then, put a nasal RAE tube in one side of the nostril, inflate the cuff, make the catheter in a natural position after inflation, clip the other side of the nostril, close the lip with tape, connect the breathing circuit, record the actual tidal volume; measure the expired tidal volume during pressure-controlled ventilation (10, 15, 20 cm H2O).Subject will start with one technique and then cross over to the other technique.
• nasal ventilation crossover face mask ventilation
Group B first placed a nasal RAE tube in one side of the nostril, the cuff was inflated, the catheter was in a natural position after inflation, the other side of the nostril was clamped, the lip was closed with tape, the breathing circuit was connected, and the amount of tidal volume was measured under pressure-controlled mode ( 10,15,20cm H2O) ; switch to volume-controlled ventilation mode (6,8,10ml/kg predicted body weight), record the actual tidal volume; pull out the tracheal tube, perform mask ventilation, record the actual tidal volume and tidal volume under volume-controlled mode(6,8,10ml/kg predicted body weight) and pressure-controlled mode (10, 15, 20 cm H2O) , respectively.Subject will start with one technique and then cross over to the other technique.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in expired tidal volume of each technique under pressure-controlled mode		3 breaths of expired tidal volume for each technique
Primary	Difference in air leakage of each technique under volume-controlled mode		3 breaths of air leakage for each technique
Secondary	number of participants with Oxygen Saturation- Reading Below 95%		intraoperative duration of each ventilation technique
Secondary	peak inspiratory pressure		intraoperative duration of each ventilation technique
Secondary	end tidal CO2 partial pressure Reading- Median		intraoperative duration of each ventilation technique
Secondary	hemodynamic changes		intraoperative duration of each ventilation technique