Feasibility of Preoxygenation by Supraglottic Jet Ventilation Before Endotracheal Intubation

NCT ID: NCT04385511

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-19
• Study Completion Date: 2020-12-31

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.

Conditions

Preoxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

supraglottic jet ventilation group

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.

Group Type: EXPERIMENTAL

supraglottic jet ventilation

Intervention Type: DEVICE

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.

mask pressurized ventilation group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hansheng Liang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hansheng Liang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hansheng Liang, MD

Role: CONTACT

doctorlianghsh@sina.com

13717929362

Facility Contacts

Yi Feng

Role: primary

010-88325581

Other Identifiers

2020PHB014-01

Identifier Type: -

Identifier Source: org_study_id