Nasal Ventilation vs Face Mask

NCT03853239 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-07

No results posted yet for this study

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.

Conditions

  • Nasotracheal Intubation

Interventions

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.

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-08-01
Completion
2019-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853239 on ClinicalTrials.gov