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Trial record 57 of 619 for:    oximeter

Cerebral Oxygenation in Total Hip Arthroplasty Patients (THANIRS)

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ClinicalTrials.gov Identifier: NCT02325154
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.

Condition or disease Intervention/treatment
Cerebral Oxygen Desaturation Post-operative Delirium Device: Cerebral Oximeter

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Near-Infrared Spectroscopy and Hypotensive Anesthesia in Patients Undergoing Total Hip Arthroplasty
Study Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
THA Patients
Patients undergoing unilateral total hip arthroplasty
Device: Cerebral Oximeter
Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Other Name: oximeter




Primary Outcome Measures :
  1. Oxygen Desaturation (incidence of intra-operative cerebral oxygen desaturation event) [ Time Frame: Intra-op ]
    incidence of intra-operative cerebral oxygen desaturation event


Secondary Outcome Measures :
  1. Duration of Oxygen Desaturation [ Time Frame: Intra-op ]
    Duration of cerebral oxygen desaturation

  2. Presence of post-operative delirium [ Time Frame: Post-op Day 1, Post-op Day 2 ]
    Presence of post-operative delirium

  3. Cognitive dysfunction [ Time Frame: Post-op Day 1, Post-op Day 2 ]
    Cognitive dysfunction as identified by deviations in mini-Cog



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hospital for Special Surgery patients scheduled to undergo unilateral total hip arthroplasty under hypotensive anesthesia
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325154


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Sean Garvin, MD Hospital for Special Surgery, New York

Publications of Results:

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02325154     History of Changes
Other Study ID Numbers: 2014-047
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders