Cerebral Oxygenation in Total Hip Arthroplasty Patients (THANIRS)
Primary Purpose
Cerebral Oxygen Desaturation, Post-operative Delirium
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cerebral Oximeter
Sponsored by
About this trial
This is an interventional other trial for Cerebral Oxygen Desaturation
Eligibility Criteria
Inclusion Criteria:
- Patients 18-80 years old undergoing unilateral total hip arthroplasty
- Hypotensive epidural anesthesia
Exclusion Criteria:
- 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)
- 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.
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
THA Patients
Arm Description
Patients undergoing unilateral total hip arthroplasty
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of Oxygen Desaturation
Duration of cerebral oxygen desaturation
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.
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.
Full Information
NCT ID
NCT02325154
First Posted
December 4, 2014
Last Updated
March 9, 2023
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT02325154
Brief Title
Cerebral Oxygenation in Total Hip Arthroplasty Patients
Acronym
THANIRS
Official Title
Cerebral Near-Infrared Spectroscopy and Hypotensive Anesthesia in Patients Undergoing Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Oxygen Desaturation, Post-operative Delirium
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THA Patients
Arm Type
Experimental
Arm Description
Patients undergoing unilateral total hip arthroplasty
Intervention Type
Device
Intervention Name(s)
Cerebral Oximeter
Other Intervention Name(s)
oximeter
Intervention Description
Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Primary Outcome Measure Information:
Title
Oxygen Desaturation Incidences
Description
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.
Time Frame
Intra-operation (when the patient enters the operating room, up to 4 hours)
Secondary Outcome Measure Information:
Title
Duration of Oxygen Desaturation
Description
Duration of cerebral oxygen desaturation
Time Frame
Intra-op ( during the time the patient is in the operating room, up to 4 hours)
Title
Presence of Post-operative Delirium
Description
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.
Time Frame
Post-op Day 1, Post-op Day 2
Title
Patients With Cognitive Dysfunction
Description
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.
Time Frame
Post-op Day 1, Post-op Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients 18-80 years old undergoing unilateral total hip arthroplasty
Hypotensive epidural anesthesia
Exclusion Criteria:
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)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Garvin, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7791257
Citation
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.
Results Reference
background
PubMed Identifier
15765453
Citation
Sharrock 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 Reference
result
PubMed Identifier
22754416
Citation
Rade 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 Reference
result
PubMed Identifier
21866430
Citation
Yadeau 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 Reference
result
PubMed Identifier
22962570
Citation
Papadopoulos 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 Reference
result
PubMed Identifier
22732435
Citation
McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.
Results Reference
result
PubMed Identifier
20508134
Citation
Murphy 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.
Results Reference
result
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Cerebral Oxygenation in Total Hip Arthroplasty Patients
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