UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056751 |
|---|---|
| Receipt number | R000064855 |
| Scientific Title | Factors Influencing Failed Extubation in the Operating Room: A Study of Postoperative Neurosurgery Patients |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/01/18 02:52:28 |
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Basic information
Public title
RISK FACTORS FOR FAILED EXTUBATION IN THE OPERATING ROOM, IN POSTOPERATIVE NEUROSURGERY PATIENTS
Acronym
REFEER: Risk Extubation Factors in Extubation in the Operating Room for Postoperative Neurosurgery Patients.
Scientific Title
Factors Influencing Failed Extubation in the Operating Room: A Study of Postoperative Neurosurgery Patients
Scientific Title:Acronym
FIEEOR:
Factors Influencing Failed Extubation in the Operating Room.
Region
| North America |
Condition
Condition
Postoperative neurosurgery recovery. This study focuses on patients who have undergone neurosurgical procedures and are in the recovery phase. We aim to evaluate the risk factors associated with failed extubation in the operating room during this critical post-anesthesia period.
Classification by specialty
| Neurology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to identify and analyze the risk factors associated with failed extubation in patients who have undergone neurosurgery. This case-control study aims to investigate the differences between two groups: Group A (cases) consisting of patients who experienced failed extubation within 48 hours post-neurosurgery and Group B (controls) composed of patients who successfully extubated during general anesthesia without requiring re-intubation.
Secondary objectives include:
To evaluate the impact of patient demographic factors such as age, sex, and comorbidities on extubation outcomes.
To assess the relationship between surgical variables (e.g., duration of surgery, intraoperative hemodynamic stability, and blood loss) and the incidence of extubation failure.
To analyze the presence of postoperative complications (such as Glasgow Coma Scale scores, cerebral edema, hypoxemia, and residual muscle relaxant blockade) and their association with extubation success or failure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of Failed Extubation: The primary outcome measure will be the incidence of failed extubation within the first 48 hours post-neurosurgery. This will be assessed by identifying patients from Group A who required re-intubation and recording the number of such cases.
Timing of Measurement: The incidence will be measured at the 48-hour postoperative mark.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Control Group (Group B): Patients who successfully extubated during general anesthesia in the operating room and were able to maintain spontaneous ventilation without ventilatory support for 48 hours post-neurosurgery. This group serves as a comparison to assess the incidence and risk factors associated with failed extubation in the study population.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 69 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of both genders aged 18 years and older.
Patients who have undergone neurosurgery and were extubated during the anesthesia procedure in the operating room.
Patients who are able to maintain spontaneous ventilation without ventilatory support for 48 hours post-neurosurgery (for the control group).
Patients who experienced failed extubation and required re-intubation within the first 48 hours post-neurosurgery (for the case group).
Key exclusion criteria
Patients who were intubated upon leaving the operating room.
Patients with incomplete medical records or those who had missing documentation.
Patients who experienced loss of record of their surgical procedure.
Patients who had significant pre-existing medical conditions that may affect the extubation process (e.g., severe respiratory disorders).
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | JUAN FRANCISCO |
| Middle name | LOPEZ |
| Last name | BURGOS |
Organization
U.M.A.E. Specialized Hospital Dr. Antonio Fraga Mouret of the National Medical Center La Raza of the I.M.S.S. U.N.A.M.
Division name
ANESTESIOLOLOGY
Zip code
02990
Address
P de las Jacarandas SN, La Raza Azcapotzalco
TEL
52015530111179
pacolobu2@hotmail.com
Public contact
Name of contact person
| 1st name | MOISES |
| Middle name | VILLASEnOR |
| Last name | ALMARAZ |
Organization
IMSS
Division name
ANESTESIOLOGY
Zip code
02990
Address
P de las Jacarandas SN La Raza, Azcapotzalco
TEL
5584244399
Homepage URL
yuseimoy@gmail.com
Sponsor or person
Institute
U.M.A.E. Specialized Hospital Dr. Antonio Fraga Mouret of the National Medical Center La Raza of the I.M.S.S. U.N.A.M.
Institute
Department
Personal name
Funding Source
Organization
U.M.A.E. Specialized Hospital Dr. Antonio Fraga Mouret of the National Medical Center La Raza of the I.M.S.S. U.N.A.M.
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mexican Social Security Institute (I.M.S.S.)
Address
P de las Jacarandas SN La Raza Azcapotzalco
Tel
800 623 2323
yuseimoy@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064855
