Infratentorial NeoplasmsPRICE1NCT05192733
PRICE Survey Of Extubation Following Infratentorial Craniotomy
An observational study of Infratentorial Neoplasms, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The PRICE study primarily aims to identify predictors of early extubation following elective infratentorial craniotomy in adults. It also aims to (i) measure the rate of early extubation in different clinical settings; and (ii) study how the decision to extubate early is made and communicated in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infratentorial Neoplasms
- What is being tested?
- Survey
- How many people
- 190 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Nov 2021to 15 Feb 2022
- 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
- Adult, Older adult
Study population: Physicians involved in delivering care to neurosurgical patients: neuroanesthesiologists, neurosurgeons, neurocritical care specialists
Who may be able to join
- Physician actively involved in delivering care to neurosurgical patients
- Physician formerly involved in delivering care to neurosurgical patients
Who cannot join
- Has already completed the survey
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: An International, Multisociety Practice Survey Of Extubation Following Elective Infratentorial Craniotomy In Adult Neurosurgical Patients
The PRICE study primarily aims to identify predictors of early extubation following elective infratentorial craniotomy in adults. It also aims to (i) measure the rate of early extubation in different clinical settings; and (ii) study how the decision to extubate early is made and communicated in clinical practice. The first phase of the study (PRICE1) is a brief online survey addressed to physicians in charge of neurosurgical patients (neuroanesthesiologists, neurosurgeons, neurocritical care specialists) in multiple countries.
- Conditions
- Infratentorial Neoplasms
- Being tested
- Survey
- Keywords
- Airway Extubation, Prediction, Prevalence, Survey
- Medical subject headings
- Infratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
This is a cross-sectional practice survey. There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Specialty | We will compare responses across the following clinical specialties :
1. Neuroanesthesiologists
2. Neurosurgeons
3. Neurocritical care specialists NB: Some participants may have a double clinical specialty. Receives: Other: Survey | |
| Clinical Setting | We will compare responses across the following clinical settings:
1. Cities
2. Countries
3. Number of cases per year Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of early extubation
Percentage of patients being extubated early, as estimated by responders. Early extubation is defined as extubation at the end of surgery, in the operating room, prior to discharge to recovery or intensive care.
Measured: 3 months
Secondary outcomes (2)
Inventory of perceived main predictors of early extubation
Participants to the survey can select up to 3 of the following options:
Survey options are:
Patient's level of consciousness Evidence of brainstem dysfunction Patient's physical status prior to surgery History or suspicion of difficult airway Preoperative imaging Duration of surgery Course of surgery Time of day when surgery ends Other (to be completed by responder)
Measured: 3 months
Personnel perceived to make the decision to extubate early
Participants to the survey can select 1 or several of the following options:
Anesthesiologist Neurosurgeon Neurocritical care physician
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start4 Nov 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infratentorial NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Hervé Quintard, Torstein Meling, Nicolai Goettel, Lien Jakus, Camille Levy
- Responsible party
- Principal investigator, John Gaudet, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192733
- Sponsor's protocol ID
- Req-2021-01236
- Acronym
- PRICE1
- Status last verified
- Mar 2022
- First submitted
- 13 Dec 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cata JP, Saager L, Kurz A, Avitsian R. Successful extubation in the operating room after infratentorial craniotomy: the Cleveland Clinic experience. J Neurosurg Anesthesiol. 2011 Jan;23(1):25-9. doi: 10.1097/ANA.0b013e3181eee548.
PubMed 21252705Cai YH, Wang HT, Zhou JX. Perioperative Predictors of Extubation Failure and the Effect on Clinical Outcome After Infratentorial Craniotomy. Med Sci Monit. 2016 Jul 12;22:2431-8. doi: 10.12659/msm.899780.
PubMed 27404044
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multisociety Practice Survey Of Extubation Following Elective Infratentorial Craniotomy In Adult Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT05192733
- Acronym / sponsor ID
- PRICE1 / Req-2021-01236
- Conditions
- Infratentorial Neoplasms
- Keywords
- Airway Extubation, Prediction, Prevalence, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Hervé Quintard, Torstein Meling, Nicolai Goettel, Lien Jakus, Camille Levy
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 14 Jan 2022 (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 PRICE study primarily aims to identify predictors of early extubation following elective infratentorial craniotomy in adults. It also aims to (i) measure the rate of early extubation in different clinical settings; and (ii) study how the decision to extubate early is made and communicated in clinical practice. The first phase of the study (PRICE1) is a brief online survey addressed to physicians in charge of neurosurgical patients (neuroanesthesiologists, neurosurgeons, neurocritical care specialists) in multiple countries.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Specialty | – | Other: SurveyWe will compare responses across the following clinical specialties : 1. Neuroanesthesiologists 2. Neurosurgeons 3. Neurocritical care specialists NB: Some participants may have a double clinical specialty. |
| Clinical Setting | – | Other: SurveyWe will compare responses across the following clinical settings: 1. Cities 2. Countries 3. Number of cases per year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Physicians involved in delivering care to neurosurgical patients: neuroanesthesiologists, neurosurgeons, neurocritical care specialists
Key inclusion criteria (2 listed)
- Physician actively involved in delivering care to neurosurgical patients
- Physician formerly involved in delivering care to neurosurgical patients
Key exclusion criteria (1 listed)
- Has already completed the survey
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 |
|---|---|---|
| SurveyThis is a cross-sectional practice survey. There is no intervention. | Other | Clinical Setting, Clinical Specialty |
Primary outcome
Prevalence of early extubation
Time frame: 3 months
Percentage of patients being extubated early, as estimated by responders. Early extubation is defined as extubation at the end of surgery, in the operating room, prior to discharge to recovery or intensive care.
2 secondary outcomes
Inventory of perceived main predictors of early extubation
Time frame: 3 months
Personnel perceived to make the decision to extubate early
Time frame: 3 months
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 22 Mar 2022.
- Background: PubMed 21252705Cata JP, Saager L, Kurz A, Avitsian R. Successful extubation in the operating room after infratentorial craniotomy: the Cleveland Clinic experience. J Neurosurg Anesthesiol. 2011 Jan;23(1):25-9. doi: 10.1097/ANA.0b013e3181eee548.
- Background: PubMed 27404044Cai YH, Wang HT, Zhou JX. Perioperative Predictors of Extubation Failure and the Effect on Clinical Outcome After Infratentorial Craniotomy. Med Sci Monit. 2016 Jul 12;22:2431-8. doi: 10.12659/msm.899780.
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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 Infratentorial Neoplasms, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 22 Mar 2022. 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 Switzerland. 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?
Prevalence of early extubation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192733, which also lists 2 linked publications.
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 22 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.