Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00991328
• Other study ID #: GCO # 07-0332
• Status: Terminated
• Phase: Phase 3
• First received: October 2, 2009
• Last updated: September 14, 2016
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether brain oxygenation measured by cerebral oximeter has an impact on neurocognitive dysfunction.

Description:

Both postoperative delirium (PD) and postoperative cognitive dysfunction (POCD) are well known complications seen in elderly patients after cardiac surgery. The etiologies of PD and POCD are unknown, but cerebral ischemia remains a prime candidate. Attempts to correlate reduced levels of systemic oxygenation (i.e. SpO2) with the development of PD/POCD have been to date disappointing.

We believe that cerebral oximetry, a noninvasive technology that continuously monitors cerebral tissue oxygen saturation (SctO2), will enable us to answer the question of whether or not a correlation exists.

The availability of an absolute cerebral oximeter (FORE-SIGHT), with its ability to establish and manipulate threshold values for SctO2, provides us the opportunity to assess the relationship between cerebral oxygenation and the development of neurocognitive complications.

We propose a randomized, masked trial of 120 patients, adequately powered to assess the following:

• Is there an association between deficits in cerebral oxygenation and the occurrence of PD at some time in the 1st 5 days after the operation?

• Is there an association between deficits in cerebral oxygenation and changes in POCD scores shortly (5 days) after the operation and/or 4-6 weeks later? We hypothesize that individually tailored patient management guided with intraoperative and postoperative absolute cerebral oximetry monitoring using a tailored protocol designed to maintain SctO2 values above a specific threshold will result in improved neurocognitive outcomes in geriatric patients undergoing cardiac surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 and older

• Elective cardiac or thoracic aortic surgery

• Capable and willing to consent

• Participants literate in English

Exclusion Criteria:

• Emergency Surgery

• Major Neurological Disease

• Gross Cognitive Dysfunction

• Patients not expected to be able to complete the 1 week and 3 months post-operative visit.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Delirium
• Post-Operative Delirium
• Postoperative Cognitive Dysfunction

Intervention

Procedure:
• SctO2 < 60 %.
The following intervention protocol will be applied when SctO2 level falls below 60 %. First, the patients head position will be checked for suitable position and the face will be observed for plethora. Then the efforts will be made to maintain PaCO2 between 40-50 mmHg and MAP of 60 - 80 mm Hg. Cardiac index will be maintained between 2.0 - 2.5 L/min/m2. The hematocrit should be more than 20 %. The red blood cells or hemoconcentration will be used for this purpose.

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association of Postoperative Delirium (PD) and Postoperative Cognitive Dysfunction (POCD) with changes in cerebral tissue oxygen saturation (SctO2).		First 5 days after the cardiac surgery.	No
Secondary	Postoperative Morbidity and Mortality		3 months postoperatively	No