NCT03853239

Nasal Ventilation vs Face Mask

Status unknown NA Last updated 7 March 2019

What this trial tests

NA trial testing face mask ventilation crossover nasal ventilation in Nasotracheal Intubation in 40 participants. Status unknown.

Timeline

1 March 2019

Primary endpoint
1 August 2019

1 August 2019

Quick facts

Lead sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 March 2019
Primary completion	1 August 2019
Estimated completion	1 August 2019
Sites	1 location across China

Drugs / interventions tested

• face mask ventilation crossover nasal ventilation
• nasal ventilation crossover face mask ventilation

Conditions studied

• Nasotracheal Intubation — all drugs for Nasotracheal Intubation →

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Who can join

Adults 18 to 55, any sex, with Nasotracheal Intubation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.