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Clinical Trials/NCT03853239
NCT03853239
Unknown
Not Applicable

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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country40 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nasotracheal Intubation
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment
40
Locations
1
Primary Endpoint
Difference in expired tidal volume of each technique under pressure-controlled mode
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
August 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible Party
Principal Investigator
Principal Investigator

Yu Sun

Principal Investigator

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

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

Outcomes

Primary Outcomes

Difference in expired tidal volume of each technique under pressure-controlled mode

Time Frame: 3 breaths of expired tidal volume for each technique

Difference in air leakage of each technique under volume-controlled mode

Time Frame: 3 breaths of air leakage for each technique

Secondary Outcomes

  • number of participants with Oxygen Saturation- Reading Below 95%(intraoperative duration of each ventilation technique)
  • hemodynamic changes(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)

Study Sites (1)

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