Subdural Pressure During Supratentorial Brain Tumour ResectionNCT02093117
Neurosurgery Recruitment Maneuver Study
A study testing Recruitment maneuver in people with Subdural Pressure During Supratentorial Brain Tumour Resection, run by University of British Columbia at 1 site in Canada.
Trial summary
Background. Patients undergoing neurosurgical procedures experience higher rates of postoperative respiratory failure compared to the broader surgical population. Lung-protective ventilation strategies, including alveolar recruitment maneuvers may be beneficial. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Subdural Pressure During Supratentorial Brain Tumour Resection
- What is being tested?
- Recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Nov 2015
- Phase
- Interventional
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (greater than 18 years of age) scheduled for craniotomy for resection of a supratentorial brain tumour who are American Society of Anesthesiologist's class I to III are eligible to participate.
Who cannot join
- Patient with altered level of consciousness or unstable/deteriorating neurologic status preoperatively will be excluded.
- In addition, if the neurosurgeon considers the mass effect too great to safely participate the patient will be excluded. Baseline subdural pressure will be measured prior to randomization
- Patients with a subdural pressure greater than 20 mmHg will be excluded.
- Other exclusion criteria include significant cardiac disease (e.g. ejection fraction < 40 percent, significant valvular disease, pulmonary hypertension), sepsis, hypovolemia and prior lung resection or history of pneumothorax.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Alveolar Recruitment Maneuver on Subdural Pressure, Brain Swelling and Cerebral Perfusion Pressure in Patients Undergoing Supratentorial Tumour Resection
Background. Patients undergoing neurosurgical procedures experience higher rates of postoperative respiratory failure compared to the broader surgical population. Lung-protective ventilation strategies, including alveolar recruitment maneuvers may be beneficial. Despite this potential benefit, the effect of high levels of continuous airway pressure on intracranial pressure, brain swelling and cerebral perfusion must be defined prior to applying this intervention to the neurosurgical population.
Objectives. The primary objective is to determine the effect of an alveolar recruitment maneuver on subdural pressure in patients undergoing supratentorial tumour resection. The secondary objectives are to determine the effect of an alveolar recruitment maneuver on 1) brain bulk score and 2) cerebral perfusion pressure in patients undergoing supratentorial tumour resection.
Read more
Hypothesis. The investigators hypothesize that an alveolar recruitment maneuver of 30 cm of water over 30 seconds will not result in a clinically-important (>3 mmHg) increase in subdural pressure.
Methods. This single center, randomized, cross-over study will enroll 30 American Society of Anesthesiologists Classification I-III patients scheduled to undergo supratentorial brain tumour resection at Vancouver General Hospital. All patients will receive a standardized general anesthetic including invasive blood pressure monitoring. After removal of the bone flap, subdural pressure will be measured using a sterile 22-gauge plastic cannula. Brain bulk will be assessed using a validated 4-point scale. After baseline arterial and subdural pressure determination and brain swelling assessments, patients will be randomized to receive either a recruitment maneuver of 30 cm of water for 30 seconds or a sham recruitment maneuver of 5 cm of water for 30 seconds. Maximal subdural pressure and minimum mean arterial pressure during the maneuver will be noted, and the neurosurgeon will be asked to score the brain bulk. After a 2-minute equilibration period, the protocol will be repeated with the alternate group allocation.
Statistical Analysis. Our sample size calculation, based on our primary outcome (subdural pressure), determined that a sample size of 22 patients would allow us to detect a difference of 3.5 mmHg in subdural pressure assuming a type I error of 0.05, a type II error of 0.2 and two-sided significance testing. The subdural pressure during the recruitment maneuver as compared to the sham maneuver will be analyzed using a paired t-test. The brain bulk score will be compared using a Wilcoxon signed rank test. All data analysis will be performed with STATA 12.1 (StataCorp, College Station, TX).
- Being tested
- Recruitment maneuver, Sham recruitment maneuver
- Keywords
- Supratentorial neurosurgery, Recruitment maneuver, Subdural pressure, Brain relaxation, Cerebral perfusion pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment maneuverProcedure or surgery
continuous positive airway pressure of 30 cm of water for 30 seconds
Sham recruitment maneuverProcedure or surgery
Continuous positive airway pressure of 5 cm of water for 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Recruitment maneuver | Experimental | The recruitment maneuver will involve application of continuous positive airway pressure of 30 cm of water for 30 seconds. Receives: Procedure: Recruitment maneuver |
| Sham recruitment maneuver | Sham comparator | The sham recruitment maneuver will involve application of continuous positive airway pressure of 5 cm of water for 30 seconds. Receives: Procedure: Sham recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subdural pressure
Change in subdural pressure (mmHg) during a recruitment maneuver as compared to a sham recruitment maneuver
Measured: At baseline and within 30 seconds of recruitment maneuver or sham
Secondary outcomes (2)
Brain relaxation score
Change in surgeon-assessed brain relaxation score (1-4) at the end of the recruitment maneuver as compared to the sham recruitment maneuver
Measured: At baseline and within 30 seconds of recruitment maneuver or sham
Cerebral perfusion pressure
Change in cerebral perfusion pressure at the end of the recruitment maneuver as compared to the sham recruitment maneuver
Measured: At baseline and within 30 seconds of recruitment maneuver or sham
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
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 Subdural Pressure During Supratentorial Brain Tumour ResectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alana Flexman, University of British Columbia
- Investigators
- Alana Flexman, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093117
- Sponsor's protocol ID
- H14-00009
- Status last verified
- Dec 2015
- First submitted
- 13 Mar 2014
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Flexman AM, Gooderham PA, Griesdale DE, Argue R, Toyota B. Effects of an alveolar recruitment maneuver on subdural pressure, brain swelling, and mean arterial pressure in patients undergoing supratentorial tumour resection: a randomized crossover study. Can J Anaesth. 2017 Jun;64(6):626-633. doi: 10.1007/s12630-017-0863-7. Epub 2017 Mar 24.
PubMed 28342045
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Alveolar Recruitment Maneuver on Subdural Pressure, Brain Swelling and Cerebral Perfusion Pressure in Patients Undergoing Supratentorial Tumour Resection
- ClinicalTrials.gov ID
- NCT02093117
- Acronym / sponsor ID
- H14-00009
- Keywords
- Supratentorial neurosurgery, Recruitment maneuver, Subdural pressure, Brain relaxation, Cerebral perfusion pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Mar 2014 (estimated)
- 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.
Background. Patients undergoing neurosurgical procedures experience higher rates of postoperative respiratory failure compared to the broader surgical population. Lung-protective ventilation strategies, including alveolar recruitment maneuvers may be beneficial. Despite this potential benefit, the effect of high levels of continuous airway pressure on intracranial pressure, brain swelling and cerebral perfusion must be defined prior to applying this intervention to the neurosurgical population.
Objectives. The primary objective is to determine the effect of an alveolar recruitment maneuver on subdural pressure in patients undergoing supratentorial tumour resection. The secondary objectives are to determine the effect of an alveolar recruitment maneuver on 1) brain bulk score and 2) cerebral perfusion pressure in patients undergoing supratentorial tumour resection.
Hypothesis. The investigators hypothesize that an alveolar recruitment maneuver of 30 cm of water over 30 seconds will not result in a clinically-important (>3 mmHg) increase in subdural pressure.
Methods. This single center, randomized, cross-over study will enroll 30 American Society of Anesthesiologists Classification I-III patients scheduled to undergo supratentorial brain tumour resection at Vancouver General Hospital. All patients will receive a standardized general anesthetic including invasive blood pressure monitoring. After removal of the bone flap, subdural pressure will be measured using a sterile 22-gauge plastic cannula. Brain bulk will be assessed using a validated 4-point scale. After baseline arterial and subdural pressure determination and brain swelling assessments, patients will be randomized to receive either a recruitment maneuver of 30 cm of water for 30 seconds or a sham recruitment maneuver of 5 cm of water for 30 seconds. Maximal subdural pressure and minimum mean arterial pressure during the maneuver will be noted, and the neurosurgeon will be asked to score the brain bulk. After a 2-minute equilibration period, the protocol will be repeated with the alternate group allocation.
Statistical Analysis. Our sample size calculation, based on our primary outcome (subdural pressure), determined that a sample size of 22 patients would allow us to detect a difference of 3.5 mmHg in subdural pressure assuming a type I error of 0.05, a type II error of 0.2 and two-sided significance testing. The subdural pressure during the recruitment maneuver as compared to the sham maneuver will be analyzed using a paired t-test. The brain bulk score will be compared using a Wilcoxon signed rank test. All data analysis will be performed with STATA 12.1 (StataCorp, College Station, TX).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recruitment maneuver | Experimental | Procedure: Recruitment maneuverThe recruitment maneuver will involve application of continuous positive airway pressure of 30 cm of water for 30 seconds. |
| Sham recruitment maneuver | Sham comparator | Procedure: Sham recruitment maneuverThe sham recruitment maneuver will involve application of continuous positive airway pressure of 5 cm of water for 30 seconds. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (greater than 18 years of age) scheduled for craniotomy for resection of a supratentorial brain tumour who are American Society of Anesthesiologist's class I to III are eligible to participate.
Key exclusion criteria (4 listed)
- Patient with altered level of consciousness or unstable/deteriorating neurologic status preoperatively will be excluded.
- In addition, if the neurosurgeon considers the mass effect too great to safely participate the patient will be excluded. Baseline subdural pressure will be measured prior to randomization
- Patients with a subdural pressure greater than 20 mmHg will be excluded.
- Other exclusion criteria include significant cardiac disease (e.g. ejection fraction < 40 percent, significant valvular disease, pulmonary hypertension), sepsis, hypovolemia and prior lung resection or history of pneumothorax.
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 |
|---|---|---|
| Recruitment maneuvercontinuous positive airway pressure of 30 cm of water for 30 seconds | Procedure or surgery | Recruitment maneuver |
| Sham recruitment maneuverContinuous positive airway pressure of 5 cm of water for 30 seconds | Procedure or surgery | Sham recruitment maneuver |
Primary outcome
Subdural pressure
Time frame: At baseline and within 30 seconds of recruitment maneuver or sham
Change in subdural pressure (mmHg) during a recruitment maneuver as compared to a sham recruitment maneuver
2 secondary outcomes
Brain relaxation score
Time frame: At baseline and within 30 seconds of recruitment maneuver or sham
Cerebral perfusion pressure
Time frame: At baseline and within 30 seconds of recruitment maneuver or sham
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 4 May 2018.
- Derived from this study: PubMed 28342045Flexman AM, Gooderham PA, Griesdale DE, Argue R, Toyota B. Effects of an alveolar recruitment maneuver on subdural pressure, brain swelling, and mean arterial pressure in patients undergoing supratentorial tumour resection: a randomized crossover study. Can J Anaesth. 2017 Jun;64(6):626-633. doi: 10.1007/s12630-017-0863-7. Epub 2017 Mar 24.
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.
Alana Flexman, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment maneuver in people with Subdural Pressure During Supratentorial Brain Tumour Resection, run by University of British Columbia at 1 site in Canada.
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 4 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 4 May 2018. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Subdural pressure (time frame: At baseline and within 30 seconds of recruitment maneuver or sham). 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 NCT02093117, 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 4 May 2018.