Nasal Ventilation vs Face Mask

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

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.

Study Overview

• Status: Unknown
• Conditions: Nasotracheal Intubation
• Intervention / Treatment: Procedure: face mask ventilation crossover nasal ventilation; Procedure: nasal ventilation crossover face mask ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Sun, MD,PhD; Phone Number: 0086-136-1189-5542; Email: dr_sunyu@163.com
• Study Contact Backup: Name: Wenyue Hu, MM; Phone Number: 0086-180-1918-0376; Email: huwenyue08@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: face mask crossover nasal ventilation	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.
Active Comparator: nasal ventilation crossover face mask	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
number of participants with Oxygen Saturation- Reading Below 95%	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
hemodynamic changes	intraoperative duration of each ventilation technique

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: face mask; nasal ventilation
• Other Study ID Numbers: nasal ventilation vs face mask

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No