Cerebral IschemiaNCT01546636
The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
A study testing Hypocapnic group and Normocapnic group in people with Cerebral Ischemia, run by Endeavor Health at 1 site in United States.
Trial summary
The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cerebral Ischemia
- What is being tested?
- Hypocapnic group and Normocapnic group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.
Who cannot join
- Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age < 18 years 3) American Society of Anesthesiologists Physical Status IV or V.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)
Read the detailed description
Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.
- Conditions
- Cerebral Ischemia
- Being tested
- Hypocapnic group, Normocapnic group
- Keywords
- Cerebral desaturation events, Cerebral oximetry, Beach chair position
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocapnic groupOther
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Normocapnic groupOther
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
| Study group | Role | What they receive |
|---|---|---|
| Hypocapnic group | Placebo comparator | Patients will be ventilated to an ETCO2 of 30-32 mm Hg. Receives: Other: Hypocapnic group |
| Normocapnic group | Active comparator | Patients will be ventilated to an ETCO2 of 40-42 mm Hg Receives: Other: Normocapnic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Cerebral Desaturation Events
Cerebral desaturation events were measured with near-infrared spectroscopy
Measured: Intraoperative-first 2 hours
Secondary outcomes (2)
Number of Patients Experiencing Nausea and Vomiting
Assessed by recovery nurses
Measured: Postanesthesia care unit-first 2 hours
Postanesthesia Care Unit Length of Stay (Total Time)
Measured: Approximately 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startNov 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral IschemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Murphy, Endeavor Health
- Investigators
- Glenn S. Murphy, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546636
- Sponsor's protocol ID
- EH10-184
- Status last verified
- Sep 2019
- First submitted
- 2 Mar 2012
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Levin SD, Koh JL, Parikh KN, Patel SS. Effect of ventilation on cerebral oxygenation in patients undergoing surgery in the beach chair position: a randomized controlled trial. Br J Anaesth. 2014 Oct;113(4):618-27. doi: 10.1093/bja/aeu109. Epub 2014 May 23.
PubMed 24860157
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
- ClinicalTrials.gov ID
- NCT01546636
- Acronym / sponsor ID
- EH10-184
- Conditions
- Cerebral Ischemia
- Keywords
- Cerebral desaturation events, Cerebral oximetry, Beach chair position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 17 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)
Detailed description
Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypocapnic group | Placebo comparator | Other: Hypocapnic groupPatients will be ventilated to an ETCO2 of 30-32 mm Hg. |
| Normocapnic group | Active comparator | Other: Normocapnic groupPatients will be ventilated to an ETCO2 of 40-42 mm Hg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.
Key exclusion criteria (1 listed)
- Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age < 18 years 3) American Society of Anesthesiologists Physical Status IV or V.
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 |
|---|---|---|
| Hypocapnic groupPatients will be ventilated to an ETCO2 of 30-32 mm Hg. | Other | Hypocapnic group |
| Normocapnic groupPatients will be ventilated to an ETCO2 of 40-42 mm Hg | Other | Normocapnic group |
Primary outcome
Incidence of Cerebral Desaturation Events
Time frame: Intraoperative-first 2 hours
Cerebral desaturation events were measured with near-infrared spectroscopy
2 secondary outcomes
Number of Patients Experiencing Nausea and Vomiting
Time frame: Postanesthesia care unit-first 2 hours
Postanesthesia Care Unit Length of Stay (Total Time)
Time frame: Approximately 5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24860157Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Levin SD, Koh JL, Parikh KN, Patel SS. Effect of ventilation on cerebral oxygenation in patients undergoing surgery in the beach chair position: a randomized controlled trial. Br J Anaesth. 2014 Oct;113(4):618-27. doi: 10.1093/bja/aeu109. Epub 2014 May 23.
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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.
Glenn S. Murphy, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocapnic group and Normocapnic group in people with Cerebral Ischemia, run by Endeavor Health at 1 site in United States.
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 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 30 Sep 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cerebral Desaturation Events (time frame: Intraoperative-first 2 hours). 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 NCT01546636, 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 30 Sep 2019.