Patients With Uncertain Difficult AirwayNCT04434963
Safety and Feasibility of Reversible Induction Strategy
An observational study of Patients With Uncertain Difficult Airway and Colon Cancer, run by RenJi Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Uncertain Difficult Airway, Colon Cancer, Gastric Cancer
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an uncertain difficult airway, who will undergo a selective operation and need trachea intubtion.
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
diansan su, +862168383702, diansansu@yahoo.com
About this study
Official title: Safety and Feasibility of Reversible Induction Strategy Supported by HFNC Combined With Specific Anesthetic
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.
- Keywords
- THRIVE, Uncertain difficult airway, Reversible induction strategy
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful rate of reversion
Measured: From the beginning of induction to 15min later
Secondary outcomes (4)
TOFr 0.9 reversion time
Measured: From the beginning of induction to 15min later
BIS 80 reversion time
Measured: From the beginning of induction to 15min later
Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time
Measured: From the beginning of induction to 15min later
consciousness reversion time
Measured: From the beginning of induction to 15min later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Feb 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Uncertain Difficult AirwayStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
- Investigators
- diansan su, Study director, Renji Hospital, Shanghai Jiaotong University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434963
- Sponsor's protocol ID
- RenjiH6502
- Status last verified
- Sep 2021
- First submitted
- 15 Jun 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is unavailable to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Reversible Induction Strategy Supported by HFNC Combined With Specific Anesthetic
- ClinicalTrials.gov ID
- NCT04434963
- Acronym / sponsor ID
- RenjiH6502
- Keywords
- THRIVE, Uncertain difficult airway, Reversible induction strategy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an uncertain difficult airway, who will undergo a selective operation and need trachea intubtion.
Key inclusion criteria (6 listed)
- >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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful rate of reversion
Time frame: From the beginning of induction to 15min later
4 secondary outcomes
TOFr 0.9 reversion time
Time frame: From the beginning of induction to 15min later
BIS 80 reversion time
Time frame: From the beginning of induction to 15min later
Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time
Time frame: From the beginning of induction to 15min later
consciousness reversion time
Time frame: From the beginning of induction to 15min later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No. IPD is unavailable to other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
diansan su study director
Renji Hospital, Shanghai Jiaotong University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Uncertain Difficult Airway and Colon Cancer, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact diansan su (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful rate of reversion (time frame: From the beginning of induction to 15min later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.