Neurosurgical ProceduresNCT06591624
Prolonged Mechanical Ventilation in Neurosurgical Patients:
An observational study of Neurosurgical Procedures and Neurosurgical Patients, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgical Procedures, Neurosurgical Patients, Prolonged Mechanical Ventilation
- What is being tested?
- Prolonged Mechanical Ventilation and remain intubation after surgery
- How many people
- 340 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jan 2021to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. The patients were excluded if they had pre-operative definite airway control such as intubation or tracheostomy.
Who may be able to join
- adult neurosurgical patients
- undergo elective surgery
Who cannot join
- already intubation before neurosurgical procedures
- tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence and Analysis of Factors Related to Prolonged Mechanical Ventilation in Neurosurgical Patients: a Retrospective Cohort Study
The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. The patients were excluded if they had pre-operative definite airway control. The primary outcome was extubation success in the operating theater. Prolonged mechanical ventilation (PMV) means the patients who could not undergo the weaning protocol and extubation in 48 hours of surgery. The secondary outcome was the features associated with the prolonged mechanical ventilation.
Read the detailed description
Extubation in operating theater after elective intracranial surgery is superlative. Early extubation strategy should be planned in preoperative period jointly with neurosurgical team. Any deviations from the plan should be identified, whether they originated from surgical aspects or anesthetic managements. The time-point for extubation in neurosurgical patients is more challenging compared to other non-brain surgeries. We identified some potential prognostic impacts to prolonged mechanical ventilation in elective neurosurgical patients.
The study was approved by the Institution Research Ethics Committee Panel 5, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. (ANE-2565-09317). The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. The patients were excluded if they had pre-operative definite airway control. The primary outcome was extubation success in the operating theater. Prolonged mechanical ventilation (PMV) means the patients who could not undergo the weaning protocol and extubation in 48 hours of surgery. The secondary outcome was the features associated with the prolonged mechanical ventilation. For continuous data, we used the student's t-test. For categorical data, we used the Fisher's exact or Chi-square test. Univariate analysis and multiple logistic regression were used to identified the prognostic factors. P values \< 0.05 indicated statistical significance.
- Being tested
- Prolonged Mechanical Ventilation, remain intubation after surgery
- Keywords
- ventilator dependent, neurosurgical patient, prolonged mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Mechanical VentilationOther
The neurosurgical patients who could extubated within 24 h after surgery
remain intubation after surgeryOther
could not extubated after surgery and prolong mechanical ventilation for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| elective adult neurosurgical patients succesfully extubation after neurosurgery | succesfully extubation after neurosurgery Receives: Other: remain intubation after surgery | |
| elective adult neurosurgical patients prolonged mechanical ventilation | prolonged mechanical ventilation Receives: Other: Prolonged Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
to be able to extubate after neurosurgery
successful extubation
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosurgical ProceduresStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pathomporn Pin on, M.D., Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591624
- Sponsor's protocol ID
- ANE-2565-09317
- Other IDs
- Chiang Mai University
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Analysis of Factors Related to Prolonged Mechanical Ventilation in Neurosurgical Patients: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06591624
- Acronym / sponsor ID
- ANE-2565-09317
- Keywords
- ventilator dependent, neurosurgical patient, prolonged mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Sep 2024 (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.
The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. The patients were excluded if they had pre-operative definite airway control. The primary outcome was extubation success in the operating theater. Prolonged mechanical ventilation (PMV) means the patients who could not undergo the weaning protocol and extubation in 48 hours of surgery. The secondary outcome was the features associated with the prolonged mechanical ventilation.
Detailed description
Extubation in operating theater after elective intracranial surgery is superlative. Early extubation strategy should be planned in preoperative period jointly with neurosurgical team. Any deviations from the plan should be identified, whether they originated from surgical aspects or anesthetic managements. The time-point for extubation in neurosurgical patients is more challenging compared to other non-brain surgeries. We identified some potential prognostic impacts to prolonged mechanical ventilation in elective neurosurgical patients.
The study was approved by the Institution Research Ethics Committee Panel 5, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. (ANE-2565-09317). The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. The patients were excluded if they had pre-operative definite airway control. The primary outcome was extubation success in the operating theater. Prolonged mechanical ventilation (PMV) means the patients who could not undergo the weaning protocol and extubation in 48 hours of surgery. The secondary outcome was the features associated with the prolonged mechanical ventilation. For continuous data, we used the student's t-test. For categorical data, we used the Fisher's exact or Chi-square test. Univariate analysis and multiple logistic regression were used to identified the prognostic factors. P values \< 0.05 indicated statistical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elective adult neurosurgical patients succesfully extubation after neurosurgery | – | Other: remain intubation after surgerysuccesfully extubation after neurosurgery |
| elective adult neurosurgical patients prolonged mechanical ventilation | – | Other: Prolonged Mechanical Ventilationprolonged mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was carried out at the neurosurgical operating theater and neurosurgical intensive care unit, Maharaj Nakorn Chiang Mai University-Hospital. The study design was a retrospective Cohort study, recruited elective adult neurosurgical patients during December 1, 2021 to December 31, 2022. The patients were excluded if they had pre-operative definite airway control such as intubation or tracheostomy.
Key inclusion criteria (2 listed)
- adult neurosurgical patients
- undergo elective surgery
Key exclusion criteria (2 listed)
- already intubation before neurosurgical procedures
- tracheostomy
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 |
|---|---|---|
| Prolonged Mechanical VentilationThe neurosurgical patients who could extubated within 24 h after surgery | Other | elective adult neurosurgical patients prolonged mechanical ventilation |
| remain intubation after surgerycould not extubated after surgery and prolong mechanical ventilation for 48 hours | Other | elective adult neurosurgical patients succesfully extubation after neurosurgery |
Primary outcome
to be able to extubate after neurosurgery
Time frame: within 24 hours after surgery
successful extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Neurosurgical Procedures and Neurosurgical Patients, run by Chiang Mai University at 1 site in Thailand.
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 2 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to be able to extubate after neurosurgery (time frame: within 24 hours after surgery). 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 19 Sep 2024.