Feasibility of Preoxygenation by Supraglottic Jet Ventilation Before Endotracheal Intubation

Preoxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385511
• Other study ID #: 2020PHB014-01
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2020
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Peking University People's Hospital
• Contact: Hansheng Liang, MD
• Phone: 13717929362
• Email: doctorlianghsh[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Preoxygenation

Intervention

Device:
• supraglottic jet ventilation
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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alveolar oxygen tension(PaO2)	The results comes from blood gas analysis	3 minutes after preoxygenation
Primary	alveolar oxygen tension(PaO2)	The results comes from blood gas analysis	baseline (before preoxygenation)
Secondary	PaCO2	The results comes from blood gas analysis	3 minutes after preoxygenation
Secondary	PaCO2	The results comes from blood gas analysis	baseline (before preoxygenation)
Secondary	gastric antrum cross section	The results comes from the ultrasound of gastric	3 minutes after preoxygenation
Secondary	gastric antrum cross section	The results comes from the ultrasound of gastric	baseline (before preoxygenation)
Secondary	complications	such as nasal bleeding, dry throat itching, sore throat, nausea and vomiting, pressure and other adverse reactions	1 day