Safety and Feasibility of Reversible Induction Strategy

NCT04434963 | Unknown

• 1 other identifier: RenjiH6502
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study would explore the safety and feasibility of a reversible induction strategy for uncertain difficult airway. This reversible induction strategy would include high flow nasal canular oxygenation support, short-term effect anesthetic including Propofol and Remifentanil for sedation and analgesia and Sugammadex would be used for reverse the muscle relaxant.

Conditions

Patients With Uncertain Difficult Airway; Colon Cancer; Gastric Cancer; Prostatic Cancer

Keywords

THRIVE; Uncertain difficult airway; Reversible induction strategy

Outcome Measures

Primary Outcomes (1)

• Successful rate of reversion

  From the beginning of induction to 15min later

Secondary Outcomes (4)

• TOFr 0.9 reversion time

  From the beginning of induction to 15min later

• BIS 80 reversion time

  From the beginning of induction to 15min later

• Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time

  From the beginning of induction to 15min later

• consciousness reversion time

  From the beginning of induction to 15min later

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an uncertain difficult airway, who will undergo a selective operation and need trachea intubtion.

You may qualify if:

• \>18 years old,\<65 years old
• Signed informed consent
• Undergoing selective operation （ time of operation is over two hours）
• ASA classification I-II
• Mallampati classification 3-4
• suspicious difficult airway, but the anesthetists decide to try to rapid induction

You may not qualify if:

• Patients with several dysfunctions of liver, kidney or heart)
• Patients with a full stomach or have other risk factors of reflux aspiration
• Any medicine was taken before surgery, which might enhance or mitigate the effects of muscle relaxant
• Infection of the mouth or nose
• Allergy history of any medicine which would be used in this study
• Pregnant and lactating women
• Patients with neuromuscular disease

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Stomach Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• diansan su

  Renji Hospital, Shanghai Jiaotong University, Shanghai, China

  STUDY DIRECTOR

Central Study Contacts

diansan su

CONTACT

+862168383702; diansansu@yahoo.com

Xiaoying Chi, M.S.

CONTACT

+86 18201706040; chixiaoying@renji.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: February 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)