CraniotomyNCT03364283
Sitting Versus Horizontal Position on Craniotomies
An observational study of Craniotomy and Brain Tumor, run by Ohio State University.
Trial summary
The main objectives of this study are comparison of the incidence of intraoperative air embolism and the extent of blood loss in patients undergoing posterior cranial fossa (PCF) and pineal region (PR) surgeries in sitting and horizontal position. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Craniotomy, Brain Tumor
- What is being tested?
- Surgical position
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 23 Apr 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective craniotomies on posterior cranial fossa or pineal region were identified on each site before surgery. Patients were asked to be part of the study explaining that no intervention was necessary besides a phone call performed by the research team 3 months after their surgery.
Who may be able to join
- Patients 18 - 75 years old undergoing open posterior cranial fossa and pineal region surgery and diagnosed with space-occupying or vascular lesions willing consent to participate in the study.
Who cannot join
- Significant cardio-vascular comorbid conditions (cardiac insufficiency, recent infarction, advanced arterial hypertension)
- Advanced chronic respiratory comorbid conditions
- Uncorrected hypovolemia, anemia, hypoalbuminemia
- De-compensated acid base and electrolyte disorders
- Anticoagulated patients and patients with coagulation disorders, deep venous thrombosis (history of deep vein thrombosis or clinically established)
- Preoperative evidence of spinal or peripheral nerve dysfunction that may interfere with patient positioning.
- Cervical myelopathy
- Cervical spine disorders (atlanto-occipital arthritis, previous fractures etc.)
About this study
Official title: The Effects of Sitting Position on the Outcome During Surgery on Posterior Cranial Fossa and Pineal Region
The main objectives of this study are comparison of the incidence of intraoperative air embolism and the extent of blood loss in patients undergoing posterior cranial fossa (PCF) and pineal region (PR) surgeries in sitting and horizontal position. Additionally, the overall treatment outcome, neurological functional outcome, degree of tumor removal, clinical course in the postoperative period, and the patient satisfaction will be compared between the groups.
Read the detailed description
This was a prospective observational study to assess the effects of patient positioning during craniotomies on surgical outcomes. Patients were distributed into 2 major groups based on the surgical position: sitting and horizontal. Each group was further divided into subgroups based on the type and location of the lesion. To achieve the study goals, comparison of the 2 approaches in equivalent patient groups was performed, including comparable demographics, diagnoses, topographic location of the lesions, anesthetic approaches, and surgical experience.
The operating surgeons decided patient positioning based on clinical judgment. Type of anesthesia was defined by the anesthesiologist in charge of the patient however, it was maximally standardized for both sites. All the surgeries were performed by neurosurgeons with sufficient experience of sitting craniotomies.
- Conditions
- Craniotomy, Brain Tumor
- Being tested
- Surgical position
- Keywords
- Posterior fossa, Pineal region
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical positionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sitting Position | Sitting and semi-sitting Receives: Procedure: Surgical position | |
| Horizontal Position | Prone, lateral and park bench. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative air embolism
Measured intraoperatively with transesophageal echocardiogram and/or PETCO2 levels
Measured: Time of surgery (From surgical wound incision time until wound closure)
Secondary outcomes (3)
Degree of tumor removal
Indicated by surgeon description and/or postoperative imaging
Measured: End of surgery (closure) - Postoperative evaluation by surgeon and/or postoperative imaging performed up to 48 hours after end of surgery
Neurological function
Compared sensory-motor function, cranial nerve function and Glasgow scale before and after surgery.
Measured: End of surgery (closure) - Discharge from the hospital or up to 3 months after end of surgery, whichever came first.
Patient satisfaction
Collected on phone script during follow-up phone call
Measured: End of surgery (closure) - 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study startOct 2015
- Primary completion23 Apr 2019
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Burdenko Neurosurgery Institute
- Responsible party
- Sponsor
- Investigators
- Sergio Bergese, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364283
- Sponsor's protocol ID
- 2015H0035
- Status last verified
- Sep 2023
- First submitted
- 4 Oct 2017
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication
Publications
Mavarez-Martinez A, Israelyan LA, Soghomonyan S, Fiorda-Diaz J, Sandhu G, Shimansky VN, Ammirati M, Palettas M, Lubnin AY, Bergese SD. The Effects of Patient Positioning on the Outcome During Posterior Cranial Fossa and Pineal Region Surgery. Front Surg. 2020 Mar 13;7:9. doi: 10.3389/fsurg.2020.00009. eCollection 2020.
PubMed 32232048
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sitting Position on the Outcome During Surgery on Posterior Cranial Fossa and Pineal Region
- ClinicalTrials.gov ID
- NCT03364283
- Acronym / sponsor ID
- 2015H0035
- Conditions
- Craniotomy, Brain Tumor
- Keywords
- Posterior fossa, Pineal region
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Burdenko Neurosurgery Institute
- Study start
- Oct 2015 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 6 Dec 2017 (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 main objectives of this study are comparison of the incidence of intraoperative air embolism and the extent of blood loss in patients undergoing posterior cranial fossa (PCF) and pineal region (PR) surgeries in sitting and horizontal position. Additionally, the overall treatment outcome, neurological functional outcome, degree of tumor removal, clinical course in the postoperative period, and the patient satisfaction will be compared between the groups.
Detailed description
This was a prospective observational study to assess the effects of patient positioning during craniotomies on surgical outcomes. Patients were distributed into 2 major groups based on the surgical position: sitting and horizontal. Each group was further divided into subgroups based on the type and location of the lesion. To achieve the study goals, comparison of the 2 approaches in equivalent patient groups was performed, including comparable demographics, diagnoses, topographic location of the lesions, anesthetic approaches, and surgical experience.
The operating surgeons decided patient positioning based on clinical judgment. Type of anesthesia was defined by the anesthesiologist in charge of the patient however, it was maximally standardized for both sites. All the surgeries were performed by neurosurgeons with sufficient experience of sitting craniotomies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitting Position | – | Procedure: Surgical positionSitting and semi-sitting |
| Horizontal Position | – | –Prone, lateral and park bench. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective craniotomies on posterior cranial fossa or pineal region were identified on each site before surgery. Patients were asked to be part of the study explaining that no intervention was necessary besides a phone call performed by the research team 3 months after their surgery.
Key inclusion criteria (1 listed)
- Patients 18 - 75 years old undergoing open posterior cranial fossa and pineal region surgery and diagnosed with space-occupying or vascular lesions willing consent to participate in the study.
Key exclusion criteria (8 listed)
- Significant cardio-vascular comorbid conditions (cardiac insufficiency, recent infarction, advanced arterial hypertension)
- Advanced chronic respiratory comorbid conditions
- Uncorrected hypovolemia, anemia, hypoalbuminemia
- De-compensated acid base and electrolyte disorders
- Anticoagulated patients and patients with coagulation disorders, deep venous thrombosis (history of deep vein thrombosis or clinically established)
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 |
|---|---|---|
| Surgical position | Procedure or surgery | Sitting Position |
Primary outcome
Incidence of intraoperative air embolism
Time frame: Time of surgery (From surgical wound incision time until wound closure)
Measured intraoperatively with transesophageal echocardiogram and/or PETCO2 levels
3 secondary outcomes
Degree of tumor removal
Time frame: End of surgery (closure) - Postoperative evaluation by surgeon and/or postoperative imaging performed up to 48 hours after end of surgery
Neurological function
Time frame: End of surgery (closure) - Discharge from the hospital or up to 3 months after end of surgery, whichever came first.
Patient satisfaction
Time frame: End of surgery (closure) - 3 months after surgery
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 3 Oct 2023.
- Derived from this study: PubMed 32232048Mavarez-Martinez A, Israelyan LA, Soghomonyan S, Fiorda-Diaz J, Sandhu G, Shimansky VN, Ammirati M, Palettas M, Lubnin AY, Bergese SD. The Effects of Patient Positioning on the Outcome During Posterior Cranial Fossa and Pineal Region Surgery. Front Surg. 2020 Mar 13;7:9. doi: 10.3389/fsurg.2020.00009. eCollection 2020.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication
Related trials for Craniotomy
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Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for Postoperative Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
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Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
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A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
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Real Time Craniotomy Planning Using Mixed Reality
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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.
Sergio Bergese, MD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
An observational study of Craniotomy and Brain Tumor, run by Ohio State University.
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 1 inclusion and 8 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 3 Oct 2023. 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?
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?
Incidence of intraoperative air embolism (time frame: Time of surgery (From surgical wound incision time until wound closure)). 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 NCT03364283, which also lists 1 linked publication.
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 Oct 2023.