Difficult IntubationOSAHSNCT04506346
Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient
An observational study of Difficult Intubation and Airway Obstruction, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This study evaluates the risk factors for difficult tracheal intubation in in obstructive sleep apnea hypopnea syndrome(OSAHS) patients undergoing uvulo-palato-pharyngoplast(UPPP) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Difficult Intubation, Airway Obstruction
- What is being tested?
- difficult tracheal intubation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2019to 31 Dec 2021
- How long will I take part?
- 1 Day
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate or severe obstructive sleep apnea hypopnea syndrome, which means apnea-hypopnea index( AHI) >15/h and lowest SpO2(LSpO2)<85% in polysommographic test.
Who may be able to join
- diagnosed as OSAHS.
- receive UPPP under general anesthesia in Beijing Tsinghua Changgung Hospital
- ASA grade I or II
Who cannot join
- ASA grade III or above
- had received UPPP
- had fore-teeth loosed
- obstructive sleep apnea hypopnea were caused by hypothyroidism, acromegaly, or vocal cord paralysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Prediction of Difficult Tracheal Intubation in Obstructive Sleep Apnea Hypopnea Syndrome Patient (OSAHS) Undergoing Uvulo-palato-pharyngoplasty
This study evaluates the risk factors for difficult tracheal intubation in in obstructive sleep apnea hypopnea syndrome(OSAHS) patients undergoing uvulo-palato-pharyngoplast(UPPP)
Read the detailed description
OSAHS patients are high risk group of difficult tracheal intubation. In clinical application, unexpected difficult tracheal intubation is not rare. Difficult airway is a significant problem to these patients and the physicans in terms of mortality and morbidity.
This study collects risk factors as physical examinations（including modified Mallampati grade, neck circumference, lateral clinical craniofacial assessment and body mass index ,BMI）, Stopbang scores, polysommographic parameters (including apnea-hypopnea index, AHI and lowest SpO2, LSpO2), and special radiographic parameters in head and neck region. By using statistics method, predictive model to manage risks would be established.
- Conditions
- Difficult Intubation, Airway Obstruction
- Being tested
- difficult tracheal intubation
- Keywords
- airway management, obstructive sleep apnea hypopnea syndrome, risk predictive model
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difficult tracheal intubationDiagnostic test
Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view
| Study group | Role | What they receive |
|---|---|---|
| OSAHS | patients with OSAHS, undergoing UPPP Receives: Diagnostic Test: difficult tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult Tracheal Intubation
Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view
Measured: 1min After tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start30 Sep 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huan Zhang, MD, Study chair, department of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506346
- Sponsor's protocol ID
- XMLX201824
- Acronym
- OSAHS
- Status last verified
- Aug 2020
- First submitted
- 1 Feb 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction of Difficult Tracheal Intubation in Obstructive Sleep Apnea Hypopnea Syndrome Patient (OSAHS) Undergoing Uvulo-palato-pharyngoplasty
- ClinicalTrials.gov ID
- NCT04506346
- Acronym / sponsor ID
- OSAHS / XMLX201824
- Conditions
- Difficult Intubation, Airway Obstruction
- Keywords
- airway management, obstructive sleep apnea hypopnea syndrome, risk predictive model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Aug 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 evaluates the risk factors for difficult tracheal intubation in in obstructive sleep apnea hypopnea syndrome(OSAHS) patients undergoing uvulo-palato-pharyngoplast(UPPP)
Detailed description
OSAHS patients are high risk group of difficult tracheal intubation. In clinical application, unexpected difficult tracheal intubation is not rare. Difficult airway is a significant problem to these patients and the physicans in terms of mortality and morbidity.
This study collects risk factors as physical examinations（including modified Mallampati grade, neck circumference, lateral clinical craniofacial assessment and body mass index ,BMI）, Stopbang scores, polysommographic parameters (including apnea-hypopnea index, AHI and lowest SpO2, LSpO2), and special radiographic parameters in head and neck region. By using statistics method, predictive model to manage risks would be established.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSAHS | – | Diagnostic Test: difficult tracheal intubationpatients with OSAHS, undergoing UPPP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate or severe obstructive sleep apnea hypopnea syndrome, which means apnea-hypopnea index( AHI) >15/h and lowest SpO2(LSpO2)<85% in polysommographic test.
Key inclusion criteria (3 listed)
- diagnosed as OSAHS.
- receive UPPP under general anesthesia in Beijing Tsinghua Changgung Hospital
- ASA grade I or II
Key exclusion criteria (4 listed)
- ASA grade III or above
- had received UPPP
- had fore-teeth loosed
- obstructive sleep apnea hypopnea were caused by hypothyroidism, acromegaly, or vocal cord paralysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| difficult tracheal intubationGrade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view | Diagnostic test | OSAHS |
Primary outcome
Difficult Tracheal Intubation
Time frame: 1min After tracheal intubation
Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Difficult Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
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.
Huan Zhang, MD study chair
department of anesthesia
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 Difficult Intubation and Airway Obstruction, run by Beijing Tsinghua Chang Gung 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 3 inclusion and 4 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 10 Aug 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficult Tracheal Intubation (time frame: 1min After tracheal intubation). 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 10 Aug 2020.