Clinical trial NCT02101242: Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot Study
Official title: Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Regional Cerebral Oxygen Saturation
Keywords: Near-infrared-Spectroscopy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both genders, over 18 years of age, undergoing elective surgery in general anesthesia.

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.

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

Primary outcomes:
measure: Regional cerebral oxygen saturation (rSO2)
timeFrame: Duration of elective surgery (an average of 2 hours)
Secondary outcomes:
measure: Incidence and severity of postoperative delirium
timeFrame: In the 10 - day postoperative sample period
measure: Incidence and severity of postoperative cognitive dysfunction
timeFrame: In the 10-day postoperative sample period
measure: Rate of organ complications
timeFrame: In the 10-day postoperative sample period
measure: Electrical activity of the brain
timeFrame: Duration of elective surgery (an average of 2 hours)
measure: Somatic cerebral oxygen saturation (sSO2)
timeFrame: Duration of elective surgery (an average of 2 hours)
measure: Hospital length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin
Study officials:
References: