Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot Study

Regional Cerebral Oxygen Saturation Clinical Trial

Official title:

Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02101242
• Other study ID #: ReCOSA
• Status: Terminated
• Start date: May 11, 2014
• Est. completion date: September 17, 2014

Study information

• Verified date: June 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: September 17, 2014
• Est. primary completion date: September 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Regional Cerebral Oxygen Saturation

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional cerebral oxygen saturation (rSO2)	Regional cerebral oxygen saturation (rSO2) is measured under different body positions for elective surgery	Duration of elective surgery (an average of 2 hours)
Secondary	Incidence and severity of postoperative delirium	Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM-ICU), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-V) (DSM-V), International Classification of Diseases (ICD)-10 (ICD-10)	In the 10 - day postoperative sample period
Secondary	Incidence and severity of postoperative cognitive dysfunction	Test battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test	In the 10-day postoperative sample period
Secondary	Rate of organ complications		In the 10-day postoperative sample period
Secondary	Electrical activity of the brain	Electrical activity of the brain is measured by electroencephalogram (EEG-derived) bispectral index (BIS) monitoring	Duration of elective surgery (an average of 2 hours)
Secondary	Somatic cerebral oxygen saturation (sSO2)	Somatic cerebral oxygen saturation (rSO2) of the lower limbs (absolutely and in side comparison) in cardiac surgery patients	Duration of elective surgery (an average of 2 hours)
Secondary	Hospital length of stay	Post-anaesthesia Discharge Scoring System (PADSS)	participants will be followed for the duration of hospital stay, an expected average of 4 weeks