Clinical trial NCT03853239: Nasal Ventilation vs Face Mask
Official title: A Randomised, Crossover Comparison of Nasal Ventilation vs Face Mask in Anesthetised Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasotracheal Intubation
Keywords: face mask
nasal ventilation
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in expired tidal volume of each technique under pressure-controlled mode
timeFrame: 3 breaths of expired tidal volume for each technique
measure: Difference in air leakage of each technique under volume-controlled mode
timeFrame: 3 breaths of air leakage for each technique
Secondary outcomes:
measure: number of participants with Oxygen Saturation- Reading Below 95%
timeFrame: intraoperative duration of each ventilation technique
measure: peak inspiratory pressure
timeFrame: intraoperative duration of each ventilation technique
measure: end tidal CO2 partial pressure Reading- Median
timeFrame: intraoperative duration of each ventilation technique
measure: hemodynamic changes
timeFrame: intraoperative duration of each ventilation technique
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: