NCT04385511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

May 19, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

March 24, 2020

Last Update Submit

May 19, 2020

Conditions

Preoxygenation

Keywords

jet ventilationsupraglottic

Outcome Measures

Primary Outcomes (2)

  • alveolar oxygen tension（PaO2）

    The results comes from blood gas analysis

    3 minutes after preoxygenation

  • alveolar oxygen tension（PaO2）

    The results comes from blood gas analysis

    baseline (before preoxygenation)

Secondary Outcomes (5)

  • PaCO2

    3 minutes after preoxygenation

  • PaCO2

    baseline (before preoxygenation)

  • gastric antrum cross section

    3 minutes after preoxygenation

  • gastric antrum cross section

    baseline (before preoxygenation)

  • complications

    1 day

Study Arms (2)

supraglottic jet ventilation group

EXPERIMENTAL

Check blood gas before induction without preoxygen. Take stomach-ultrasound. Induction with Midazolam 0.02 mg/kg, sufentanil 0.3 \~ 0.5 ug/kg, propofol 2-2.5 mg/kg, rocuronium 0.6 mg/kg.After patients fall asleep and can't be woke up ,the investigators will put the Wei NASAL JET（WNJ）into one's nose to give the supraglottic jet ventilation with the driving pressure 0.01-0.03 megapascal (MPa), respiratory rate 15 beats per minute（BPM）, inspiratory/expiratory rate 1-1. 5.Check blood gas,stomach-ultrasound after 3 min, then do the tracheal intubation guided by visual laryngoscope.Stop jet ventilation during intubation.

Device: supraglottic jet ventilation

mask pressurized ventilation group

NO INTERVENTION

Check blood gas before induction without preoxygen. Take stomach-ultrasound. Induction with Midazolam 0.02 mg/kg, sufentanil 0.3 \~ 0.5 ug/kg, propofol 2-2.5 mg/kg, rocuronium 0.6 mg/kg.After patients fall asleep and can't be woke up ,the investigators will give them 1 min mask pressure respiration, by pressure control "V - E technique" after muscle relaxant. Check blood gas,stomach-ultrasound after 2 min, then do the tracheal intubation guided by visual laryngoscope.

Interventions

supraglottic jet ventilationDEVICE

patients who were randomized into supraglottic jet ventilation group would be placed Wei Nasal Jet Tube after conducted. Then they will get the supraglottic jet ventilation to make sure their pulse oximetry is over 95%. After 3 minutes, endotracheal intubation was performed via mouth approach.

supraglottic jet ventilation group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Study Officials

  • Hansheng Liang, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hansheng Liang, MD

CONTACT

13717929362doctorlianghsh@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2020

First Posted

May 13, 2020

Study Start

May 19, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

CN(1)