DeliriumNCT03165539
Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
An observational study of Delirium and Thoracic Surgery, run by University of Manitoba at 1 site in Canada.
Trial summary
This study will assess the incidence and risk factors for post-operative delirium in patients undergoing thoracotomy. Specifically, the study will assess if there is any relationship between an intra-operative decrease in brain oxygen levels which can occur during one-lung ventilation, and the occurrence of delirium… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Delirium, Thoracic Surgery
- What is being tested?
- Cerebral oxygen saturation monitoring
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Feb 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thoracic surgery patients at a major healthcare centre with a requirement for one-lung ventilation.
Who may be able to join
- Patients undergoing a thoracic surgical procedure with one-lung ventilation.
Who cannot join
- Inability to communicate in English
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Department of Anesthesia, University of Manitoba
Winnipeg, Manitoba, R3E 0Z2
Stephen Kowalski, MD, 204-787-3796, sekowalski@hsc.mb.ca
Linda Girling, BScHons, 204-787-1414, lgirling@hsc.mb.ca
About this study
Official title: The Effect of Intraoperative Cerebral Oxygen Desaturation on Post-Operative Delirium in Thoracic Surgical Patients: A Pilot Study
This study will assess the incidence and risk factors for post-operative delirium in patients undergoing thoracotomy. Specifically, the study will assess if there is any relationship between an intra-operative decrease in brain oxygen levels which can occur during one-lung ventilation, and the occurrence of delirium in the post-operative period.
Read the detailed description
This will be a prospective, observational study on 200 patients. Consenting thoracic surgical patients presenting for open thoracotomy or VATS will be assessed pre-operatively for baseline cognitive status and clinically relevant risk factors for delirium. Intra-operatively, patients will undergo cerebral oxygenation monitoring using near infra-red spectroscopy cerebral oximetry. Postoperatively, patients will be assessed twice daily for the presence or absence of delirium using the Confusion Assessment Methodology (CAM) scoring system during their hospital stay.
A clinically relevant desaturation will be defined as a 25% decrease from the patient's baseline saturation, which will be determined while the patient is breathing room air pre-operatively. The severity and duration of any desaturation will be recorded and subsequently analyzed for correlation with post-operative delirium. Bivariate associations between the risk of delirium and predictor variables will be sought. If appropriate, logistic regression models will be constructed with the outcome of delirium.
Significance: Previous studies at our centre have resulted in over 35% of thoracic surgical patients developing significant, intra-operative cerebral desaturation. We propose to study a convenience sample of 200 consecutive patients. Depending on the relative risk of developing delirium with a significant cerebral desaturation, this study may be adequately powered to determine the associated risk of delirium. This study will provide background information in planning further interventional trials to prevent desaturation and possibly reduce the incidence of delirium, as well as aid in the planning of larger multi-center trials to more accurately assess the risk of intra-operative decreases in cerebral oxygenation and the role this event contributes to the occurrence of delirium.
- Conditions
- Delirium, Thoracic Surgery
- Being tested
- Cerebral oxygen saturation monitoring
- Keywords
- Postoperative, One-lung ventilation, Cerebral oximetry, Cerebral desaturation
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oxygen saturation monitoringDevice
Intraoperatively, patients will have baseline cerebral oxygen saturation monitoring while breathing room air. Cerebral oxygen saturation monitoring will continue throughout the entire operation including the time on one-lung ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic surgery patient | Pre-operatively, patients will have baseline cognitive assessment done using the Mini-mental status test and MOCA test. Intra-operatively patients' baseline cerebral saturation (%) will be measured, and continuously monitored throughout the procedure. Post-operatively, patients will be assessed for delirium using the CAM score. Receives: Device: Cerebral oxygen saturation monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Delirium vs Cerebral Desaturation
Incidence of delirium will be assessed post-operatively up to POD 5 as measured by positive Confusion Assessment Method (CAM) scores and correlated with clinically relevant cerebral desaturation (greater than a 25% decrease from baseline)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startSep 2015
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Jacobsohn, MD, Study chair, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165539
- Sponsor's protocol ID
- B2013:084
- Status last verified
- Oct 2018
- First submitted
- 23 May 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vasilevskis EE, Han JH, Hughes CG, Ely EW. Epidemiology and risk factors for delirium across hospital settings. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):277-87. doi: 10.1016/j.bpa.2012.07.003.
PubMed 23040281Berry MF, Onaitis MW, Tong BC, Harpole DH, D'Amico TA. A model for morbidity after lung resection in octogenarians. Eur J Cardiothorac Surg. 2011 Jun;39(6):989-94. doi: 10.1016/j.ejcts.2010.09.038. Epub 2011 Jan 26.
PubMed 21276728Schoen J, Meyerrose J, Paarmann H, Heringlake M, Hueppe M, Berger KU. Preoperative regional cerebral oxygen saturation is a predictor of postoperative delirium in on-pump cardiac surgery patients: a prospective observational trial. Crit Care. 2011;15(5):R218. doi: 10.1186/cc10454. Epub 2011 Sep 19.
PubMed 21929765Suehiro K, Okutai R. Duration of cerebral desaturation time during single-lung ventilation correlates with mini mental state examination score. J Anesth. 2011 Jun;25(3):345-9. doi: 10.1007/s00540-011-1136-1. Epub 2011 Apr 12.
PubMed 21484501Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
PubMed 22311364
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Cerebral Oxygen Desaturation on Post-Operative Delirium in Thoracic Surgical Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03165539
- Acronym / sponsor ID
- B2013:084
- Conditions
- Delirium, Thoracic Surgery
- Keywords
- Postoperative, One-lung ventilation, Cerebral oximetry, Cerebral desaturation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 24 May 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.
This study will assess the incidence and risk factors for post-operative delirium in patients undergoing thoracotomy. Specifically, the study will assess if there is any relationship between an intra-operative decrease in brain oxygen levels which can occur during one-lung ventilation, and the occurrence of delirium in the post-operative period.
Detailed description
This will be a prospective, observational study on 200 patients. Consenting thoracic surgical patients presenting for open thoracotomy or VATS will be assessed pre-operatively for baseline cognitive status and clinically relevant risk factors for delirium. Intra-operatively, patients will undergo cerebral oxygenation monitoring using near infra-red spectroscopy cerebral oximetry. Postoperatively, patients will be assessed twice daily for the presence or absence of delirium using the Confusion Assessment Methodology (CAM) scoring system during their hospital stay.
A clinically relevant desaturation will be defined as a 25% decrease from the patient's baseline saturation, which will be determined while the patient is breathing room air pre-operatively. The severity and duration of any desaturation will be recorded and subsequently analyzed for correlation with post-operative delirium. Bivariate associations between the risk of delirium and predictor variables will be sought. If appropriate, logistic regression models will be constructed with the outcome of delirium.
Significance: Previous studies at our centre have resulted in over 35% of thoracic surgical patients developing significant, intra-operative cerebral desaturation. We propose to study a convenience sample of 200 consecutive patients. Depending on the relative risk of developing delirium with a significant cerebral desaturation, this study may be adequately powered to determine the associated risk of delirium. This study will provide background information in planning further interventional trials to prevent desaturation and possibly reduce the incidence of delirium, as well as aid in the planning of larger multi-center trials to more accurately assess the risk of intra-operative decreases in cerebral oxygenation and the role this event contributes to the occurrence of delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic surgery patient | – | Device: Cerebral oxygen saturation monitoringPre-operatively, patients will have baseline cognitive assessment done using the Mini-mental status test and MOCA test. Intra-operatively patients' baseline cerebral saturation (%) will be measured, and continuously monitored throughout the procedure. Post-operatively, patients will be assessed for delirium using the CAM score. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thoracic surgery patients at a major healthcare centre with a requirement for one-lung ventilation.
Key inclusion criteria (1 listed)
- Patients undergoing a thoracic surgical procedure with one-lung ventilation.
Key exclusion criteria (2 listed)
- Inability to communicate in English
- Lack of informed consent
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 |
|---|---|---|
| Cerebral oxygen saturation monitoringIntraoperatively, patients will have baseline cerebral oxygen saturation monitoring while breathing room air. Cerebral oxygen saturation monitoring will continue throughout the entire operation including the time on one-lung ventilation. | Device | Thoracic surgery patient |
Primary outcome
Post-operative Delirium vs Cerebral Desaturation
Time frame: 5 days
Incidence of delirium will be assessed post-operatively up to POD 5 as measured by positive Confusion Assessment Method (CAM) scores and correlated with clinically relevant cerebral desaturation (greater than a 25% decrease from baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Background: PubMed 23040281Vasilevskis EE, Han JH, Hughes CG, Ely EW. Epidemiology and risk factors for delirium across hospital settings. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):277-87. doi: 10.1016/j.bpa.2012.07.003.
- Background: PubMed 21276728Berry MF, Onaitis MW, Tong BC, Harpole DH, D'Amico TA. A model for morbidity after lung resection in octogenarians. Eur J Cardiothorac Surg. 2011 Jun;39(6):989-94. doi: 10.1016/j.ejcts.2010.09.038. Epub 2011 Jan 26.
- Background: PubMed 21929765Schoen J, Meyerrose J, Paarmann H, Heringlake M, Hueppe M, Berger KU. Preoperative regional cerebral oxygen saturation is a predictor of postoperative delirium in on-pump cardiac surgery patients: a prospective observational trial. Crit Care. 2011;15(5):R218. doi: 10.1186/cc10454. Epub 2011 Sep 19.
- Background: PubMed 21484501Suehiro K, Okutai R. Duration of cerebral desaturation time during single-lung ventilation correlates with mini mental state examination score. J Anesth. 2011 Jun;25(3):345-9. doi: 10.1007/s00540-011-1136-1. Epub 2011 Apr 12.
- Background: PubMed 22311364Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
- Individual participant dataSharing planned: No
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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.
Eric Jacobsohn, MD study chair
University of Manitoba
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 Delirium and Thoracic Surgery, run by University of Manitoba 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 2 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: status not confirmed, as of the sponsor's last update on 16 Oct 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen E Kowalski, MD (204-787-1414, sekowalski@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Delirium vs Cerebral Desaturation (time frame: 5 days). 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 NCT03165539, which also lists 5 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 16 Oct 2018.