Cerebral Oxygen DesaturationTHANIRSNCT02325154
Cerebral Oxygenation in Total Hip Arthroplasty Patients
A study testing Cerebral Oximeter in people with Cerebral Oxygen Desaturation and Post-operative Delirium, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygen Desaturation, Post-operative Delirium
- What is being tested?
- Cerebral Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Aug 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18-80 years old undergoing unilateral total hip arthroplasty
- Hypotensive epidural anesthesia
Who cannot join
- Contraindication to controlled hypotension and/or neuraxial anesthesia.
- Severe pulmonary hypertension or pre-op systolic blood pressure reading >150 mm Hg
- Moderate to severe valvular stenosis.
- History of stroke, dementia, or post-op delirium
- Prior OSA diagnosis
- History of benzodiazepine use (regular use for longer than 3 months)
Show all 14Show fewer
- Chronic renal or hepatic disease (renal failure, history of liver failure, cirrhosis)
- History of alcoholism or heavy alcohol intake (defined as averaging more than 3 drinks per night; recovery is OK)
- Parkinson's disease
- Severe chronic pulmonary disease
- Total anterior hip approach being used
- Hip resurfacing procedure
- Non-English Speaking*
- Questionnaires being used to assess mental status are only validated in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Cerebral Near-Infrared Spectroscopy and Hypotensive Anesthesia in Patients Undergoing Total Hip Arthroplasty
We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.
Read the detailed description
The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.
- Being tested
- Cerebral Oximeter
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral OximeterDevice
Also called oximeter
Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
| Study group | Role | What they receive |
|---|---|---|
| THA Patients | Experimental | Patients undergoing unilateral total hip arthroplasty Receives: Device: Cerebral Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Desaturation Incidences
The number of participant's experiencing an intra-operative cerebral oxygen desaturation event.
Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours.
Measured: Intra-operation (when the patient enters the operating room, up to 4 hours)
Secondary outcomes (3)
Duration of Oxygen Desaturation
Duration of cerebral oxygen desaturation
Measured: Intra-op ( during the time the patient is in the operating room, up to 4 hours)
Presence of Post-operative Delirium
The number of patients who have post-operative delirium, as determined by counting the patients who suffer from this condition.
Although recorded at various time points, the total number of participants experiencing post-operative delirium was summed and reported.
Measured: Post-op Day 1, Post-op Day 2
Patients With Cognitive Dysfunction
The number of patients considered to experience cognitive dysfunction as identified by low scores on the mini-Cog.
The Mini-Cog checks for the brain function (or the cognitive impairment) of the participant. The Mini-Cog does this by examining a patient's ability in two areas. This is done via a three-word recall test and the Clock Drawing Test.
- Three-Word Recall
- The Clock Drawing Test (CDT)
There are five total points a person can score on the Mini-Cog:
- Give one point for each word that was correctly remembered. (0-3 points)
- Give two points for a correctly drawn clock, meaning the numbers are in roughly the correct locations and two hands are pointed to the 11 and the 2. The length of the hands does not matter. (0 or 2 points) If a patient scores less than three points, they are counted as experiencing cognitive dysfunction.
Although collected across different time points, the total number of patients scoring less than 3 points were summed and reported.
Measured: Post-op Day 1, Post-op Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2016
- Study completionAug 2016
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 (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral Oxygen DesaturationStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Garvin, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325154
- Sponsor's protocol ID
- 2014-047
- Acronym
- THANIRS
- Status last verified
- Apr 2024
- First submitted
- 4 Dec 2014
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
PubMed 7791257Sharrock NE, Fischer G, Goss S, Flynn E, Go G, Sculco TP, Salvati EA. The early recovery of cognitive function after total-hip replacement under hypotensive epidural anesthesia. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):123-7. doi: 10.1016/j.rapm.2004.12.005.
PubMed 15765453Rade MC, Yadeau JT, Ford C, Reid MC. Postoperative delirium in elderly patients after elective hip or knee arthroplasty performed under regional anesthesia. HSS J. 2011 Jul;7(2):151-6. doi: 10.1007/s11420-011-9195-2. Epub 2011 Feb 11.
PubMed 22754416Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.
PubMed 21866430Papadopoulos G, Karanikolas M, Liarmakopoulou A, Papathanakos G, Korre M, Beris A. Cerebral oximetry and cognitive dysfunction in elderly patients undergoing surgery for hip fractures: a prospective observational study. Open Orthop J. 2012;6:400-5. doi: 10.2174/1874325001206010400. Epub 2012 Sep 3.
PubMed 22962570McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.
PubMed 22732435Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.
PubMed 20508134
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Near-Infrared Spectroscopy and Hypotensive Anesthesia in Patients Undergoing Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02325154
- Acronym / sponsor ID
- THANIRS / 2014-047
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.
Detailed description
The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THA Patients | Experimental | Device: Cerebral OximeterPatients undergoing unilateral total hip arthroplasty |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18-80 years old undergoing unilateral total hip arthroplasty
- Hypotensive epidural anesthesia
Key exclusion criteria (14 listed)
- Contraindication to controlled hypotension and/or neuraxial anesthesia.
- Severe pulmonary hypertension or pre-op systolic blood pressure reading >150 mm Hg
- Moderate to severe valvular stenosis.
- History of stroke, dementia, or post-op delirium
- Prior OSA diagnosis
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 OximeterAlso: oximeterUse of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events. | Device | THA Patients |
Primary outcome
Oxygen Desaturation Incidences
Time frame: Intra-operation (when the patient enters the operating room, up to 4 hours)
The number of participant's experiencing an intra-operative cerebral oxygen desaturation event. Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours.
3 secondary outcomes
Duration of Oxygen Desaturation
Time frame: Intra-op ( during the time the patient is in the operating room, up to 4 hours)
Presence of Post-operative Delirium
Time frame: Post-op Day 1, Post-op Day 2
Patients With Cognitive Dysfunction
Time frame: Post-op Day 1, Post-op Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7791257Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
- Results publication: PubMed 15765453Sharrock NE, Fischer G, Goss S, Flynn E, Go G, Sculco TP, Salvati EA. The early recovery of cognitive function after total-hip replacement under hypotensive epidural anesthesia. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):123-7. doi: 10.1016/j.rapm.2004.12.005.
- Results publication: PubMed 22754416Rade MC, Yadeau JT, Ford C, Reid MC. Postoperative delirium in elderly patients after elective hip or knee arthroplasty performed under regional anesthesia. HSS J. 2011 Jul;7(2):151-6. doi: 10.1007/s11420-011-9195-2. Epub 2011 Feb 11.
- Results publication: PubMed 21866430Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.
- Results publication: PubMed 22962570Papadopoulos G, Karanikolas M, Liarmakopoulou A, Papathanakos G, Korre M, Beris A. Cerebral oximetry and cognitive dysfunction in elderly patients undergoing surgery for hip fractures: a prospective observational study. Open Orthop J. 2012;6:400-5. doi: 10.2174/1874325001206010400. Epub 2012 Sep 3.
- Results publication: PubMed 22732435McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.
- Results publication: PubMed 20508134Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.
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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.
Sean Garvin, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral Oximeter in people with Cerebral Oxygen Desaturation and Post-operative Delirium, run by Hospital for Special Surgery, New York 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 2 inclusion and 14 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 27 Dec 2024. 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. 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 1 Mar 2023). 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?
Oxygen Desaturation Incidences (time frame: Intra-operation (when the patient enters the operating room, up to 4 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 NCT02325154, which also lists 7 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 27 Dec 2024.