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Clinical Trials/NCT04385511
NCT04385511UnknownNot Applicable

Feasibility of Preoxygenation by Supraglottic Jet Ventilation Substituted for Mask Pressurized Ventilation Before Endotracheal Intubation:A Randomized Controlled Trail

Peking University People's Hospital1 site in 1 country68 target enrollmentStarted: May 19, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
68
Locations
1
Primary Endpoint
alveolar oxygen tension(PaO2)

Study Overview

Brief Summary

The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.

Detailed Description

The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.

The investigators randomly divided the patients into 2 groups:Group C and Group S.Patients in Group C will be preoxygenation with mask pressurized ventilation while patients in Group S with supraglottic jet ventilation by Wei NASAL JET(WNJ).The tracheal intubation will be done after the 3 minutes preoxygenation. The investigators will measure the PaCO2 before and after preoxygenation, and the investigators will take the stomach-ultrasonography to find if there are too much gas in the gastro. If pulse oximetry is lower than 95% during the preoxygenation, the investigators will adjust the position of the Wei NASAL JET(WNJ) or use the change the way that the investigators hold the mask or change the pressure of ventilation on the basis of the group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • scheduled for any surgery under general anesthesia
  • adults age range from 18-64 years old
  • American Society of Anesthesiologists Physical Status Classification (ASA class) I-II
  • voluntary participation in this clinical trail, signed informed consents

Exclusion Criteria

  • patients with epistaxis, rhinostenosis, the episodes of rhinitis, severe gastroesophageal reflux disease, severe respiratory disease, severe cardiovascular and cerebrovascular disease
  • long-term use if anticoagulant drugs
  • can't cooperate with intervention
  • pulse oximetry <95% with normal respiration

Outcomes

Primary Outcomes

alveolar oxygen tension(PaO2)

Time Frame: baseline (before preoxygenation)

The results comes from blood gas analysis

Secondary Outcomes

  • PaCO2(baseline (before preoxygenation))
  • gastric antrum cross section(baseline (before preoxygenation))
  • complications(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hansheng Liang

Principal Investigator

Peking University People's Hospital

Study Sites (1)

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