Regional Cerebral Oxygen Saturation Under General Anesthesia A Pilot Study

NCT02101242 | Terminated

• 1 other identifier: ReCOSA
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Cerebral Oxygen Saturation

Keywords

Near-infrared-Spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence and severity of postoperative delirium

  In the 10 - day postoperative sample period

• Incidence and severity of postoperative cognitive dysfunction

  In the 10-day postoperative sample period

• Rate of organ complications

  In the 10-day postoperative sample period

• Electrical activity of the brain

  Duration of elective surgery (an average of 2 hours)

• Somatic cerebral oxygen saturation (sSO2)

  Duration of elective surgery (an average of 2 hours)

Study Arms (3)

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.

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.

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of both genders, over 18 years of age, undergoing elective surgery in general anesthesia.

You may qualify if:

• 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:
• orthopedic surgery of the shoulder in beach chair position
• gynecological, urological or general surgery in Trendelenburg's position
• cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 10117, Germany

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: April 2, 2014
• Study Start: May 11, 2014
• Primary Completion: September 14, 2014
• Study Completion: September 17, 2014
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

DE (1)