Clinical trial NCT04385511: Feasibility of Preoxygenation by Supraglottic Jet Ventilation Before Endotracheal Intubation
Official title: Feasibility of Preoxygenation by Supraglottic Jet Ventilation Substituted for Mask Pressurized Ventilation Before Endotracheal Intubation:A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preoxygenation
Keywords: jet ventilation
supraglottic
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: alveolar oxygen tension（PaO2）
timeFrame: 3 minutes after preoxygenation
measure: alveolar oxygen tension（PaO2）
timeFrame: baseline (before preoxygenation)
Secondary outcomes:
measure: PaCO2
timeFrame: 3 minutes after preoxygenation
measure: PaCO2
timeFrame: baseline (before preoxygenation)
measure: gastric antrum cross section
timeFrame: 3 minutes after preoxygenation
measure: gastric antrum cross section
timeFrame: baseline (before preoxygenation)
measure: complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Hansheng Liang, MD
role: PRINCIPAL_INVESTIGATOR
References: