Overview

This trial is active, not recruiting.

Condition regional cerebral oxygen saturation
Sponsor Charite University, Berlin, Germany
Start date May 2014
End date January 2016
Trial size 60 participants
Trial identifier NCT02101242, ReCOSA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation during change from supine position to beach chair position.
Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation during change from supine position to Trendelenburg position.
Near-infrared spectroscopy (NIRS) can detect fluctuation of regional cerebral oxygen saturation in patients undergoing cardiac surgery with cardiopulmonary bypass (heart-lung machine).

Primary Outcomes

Measure
Regional cerebral oxygen saturation (rSO2)
time frame: Duration of elective surgery (an average of 2 hours)

Secondary Outcomes

Measure
Incidence and severity of postoperative delirium
time frame: In the 10 - day postoperative sample period
Incidence and severity of postoperative cognitive dysfunction
time frame: In the 10-day postoperative sample period
Rate of organ complications
time frame: In the 10-day postoperative sample period
Electrical activity of the brain
time frame: Duration of elective surgery (an average of 2 hours)
Somatic cerebral oxygen saturation (sSO2)
time frame: Duration of elective surgery (an average of 2 hours)
Hospital length of stay
time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.