Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot Study

NCT ID: NCT02101242

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-11
• Study Completion Date: 2014-09-17

Brief Summary

A total of 60 patients will be enrolled in the study: 20 each who receive surgery in beach chair position or Trendelenburg's position and 20 patients undergoing cardiac surgery. Regional cerebral oxygen saturation will be measured continuously during surgery. Duration and extent of deviations from individual baseline values will be recorded and detected deviations treated according to their clinically apparent cause (e.g. hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with our standard operating procedures (SOPs).

Patients are then followed up until the end of hospital stay or for a maximum of 10 days after surgery. Their level of cognitive function will be tested and compared to the data acquired before surgery to detect impairment, delirium or postoperative cognitive deficit (POCD).

The purpose of this pilot study is to evaluate the design and conduct of a projected full scale observational clinical study.

Detailed Description

The primary goal of this study is the detection of perioperative fluctuations of regional cerebral oxygen saturation in patients undergoing surgery in general anaesthesia. These fluctuations will be monitored using the a non-invasive monitoring system based on the method of near-infrared spectroscopy (NIRS).

Regional cerebral hypoxia is considered one of the possible precipitating factors of postsurgical cognitive impairment (as seen in patients with postoperative cognitive deficit or postoperative delirium), but without monitoring it may easily remain undetected. A differentiated analysis of fluctuations is gained by calculation of the area under curve (AUC) of a defined deviation from individual baseline regional cerebral oxygen saturation (rSO2) over time.

When deviations are detected, they will be treated in this study according to their clinically apparent cause (e.g. hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with current standard operating procedures (SOPs) to re-elevate regional cerebral oxygen saturation (rSO2) to within 20% of baseline.

Among these procedures are

1. Elevation of systemic arterial pressure by application of vasopressors

2. Consideration of systemic (pulse oxymetric) oxygen saturation

3. Adjustment of artificial ventilation subject to endexpiratory concentration of carbon dioxide (CO2)

4. Transfusion of concentrated red cells in case of Hemoglobin (Hb) <7-9 g/dl

5. Transthoracic or transesophageal echocardiogram (TTE/TEE) and assessment of centralvenous oxygen saturation in case of suspected myocardial insufficiency

which should be applied to patients of the 3 defined groups as needed.

This explorative project is a pilot study.

Conditions

Regional Cerebral Oxygen Saturation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Orthopedic surgery of the shoulder

Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation during change from supine position to beach chair position.

No interventions assigned to this group

Gynecological, urological or general surgery

Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation during change from supine position to Trendelenburg position.

No interventions assigned to this group

Cardiac surgery

Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation in patients undergoing cardiac surgery with cardiopulmonary bypass (heart-lung machine).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patients with male-to-female ratio approaching 1:1
• age ≥ 18 years
• scheduled duration of surgery longer than or equal to 60 minutes
• patients undergoing one of the following procedures:

1. orthopedic surgery of the shoulder in beach chair position

2. gynecological, urological or general surgery in Trendelenburg's position

3. cardiac surgery

Exclusion Criteria

• Moribund patients
• Persons without the capacity to consent
• Unability of German language use
• Inability of communication due to severe hearing and severe vision impairments
• Accommodation in an institution due to an official or judicial order
• Co-worker of the Charité
• Participation in another interventional study within 30 days before participation in this study
• Alcohol- use disorders according to the Alcohol Use Disorders Identification Test (AUDIT)
• Preoperative Dementia (Minimal Mental State Examination < 24)
• Stroke, traumatic brain injury within the last 12 months or patients with residual neurological deficits

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

ReCOSA

Identifier Type: -

Identifier Source: org_study_id