Oral InfectionPrediction modNCT06853808
Prediction Model for Delayed Extubation of Tracheal Intubation in Patients With Maxillofacial Space Infection After Abscess Incision and Drainage Surgery
An observational study of Oral Infection, run by Henan Provincial People's Hospital.
Trial summary
Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation twenty-four hours after abscess incision and drainage surgery in patients with maxillofacial space infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Infection
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with oral and maxillofacial space infection
Who may be able to join
- Age ≥ 18 years old (actual age of the patient)
- Patients diagnosed with maxillofacial space infection upon admission
Who cannot join
- Serious errors or omissions in key demographic information and medical records
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation twenty-four hours after abscess incision and drainage surgery in patients with maxillofacial space infection.
Read the detailed description
- Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation after 24 hours of abscess incision and drainage in patients with maxillofacial space infection.
- Prediction model: Based on the identified risk factors, establish a model to predict the risk of tracheal intubation withdrawal 24 hours after abscess incision and drainage surgery in patients with maxillofacial space infection.
- Conditions
- Oral Infection
- Keywords
- oral infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal group | The patient underwent incision and drainage surgery for an abscess in the maxillofacial space, and the endotracheal tube was removed 24 hours later | |
| Delay group | The patient did not remove the endotracheal tube 24 hours after undergoing incision and drainage surgery for maxillofacial abscess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for extubation of endotracheal tube after surgery
Did the patient remove the endotracheal tube within 24 hours after undergoing maxillofacial abscess incision and drainage surgery.
Measured: 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start25 Feb 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral InfectionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jiaqiang zhang, Principal investigator, Department Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853808
- Sponsor's protocol ID
- HenanPPH-whb
- Acronym
- Prediction mod
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model for Delayed Extubation of Tracheal Intubation in Patients With Maxillofacial Space Infection After Abscess Incision and Drainage Surgery
- ClinicalTrials.gov ID
- NCT06853808
- Acronym / sponsor ID
- Prediction mod / HenanPPH-whb
- Conditions
- Oral Infection
- Keywords
- oral infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 25 Feb 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Mar 2025 (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.
Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation twenty-four hours after abscess incision and drainage surgery in patients with maxillofacial space infection.
Detailed description
- Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation after 24 hours of abscess incision and drainage in patients with maxillofacial space infection.
- Prediction model: Based on the identified risk factors, establish a model to predict the risk of tracheal intubation withdrawal 24 hours after abscess incision and drainage surgery in patients with maxillofacial space infection.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal group | – | –The patient underwent incision and drainage surgery for an abscess in the maxillofacial space, and the endotracheal tube was removed 24 hours later |
| Delay group | – | –The patient did not remove the endotracheal tube 24 hours after undergoing incision and drainage surgery for maxillofacial abscess |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oral and maxillofacial space infection
Key inclusion criteria (2 listed)
- Age ≥ 18 years old (actual age of the patient)
- Patients diagnosed with maxillofacial space infection upon admission
Key exclusion criteria (1 listed)
- Serious errors or omissions in key demographic information and medical records
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
Time for extubation of endotracheal tube after surgery
Time frame: 24hour
Did the patient remove the endotracheal tube within 24 hours after undergoing maxillofacial abscess incision and drainage surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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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.
jiaqiang zhang principal investigator
Department Director
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Infection, run by Henan Provincial People's Hospital.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jiaqiang zhang (13937121360, mzkywlcss2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for extubation of endotracheal tube after surgery (time frame: 24hour). 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 3 Mar 2025.