Cerebral Oxygen Desaturation & Post-Operative Delirium in Thoracic

Status Recruiting

Clinical Trial Summary

This study will assess the incidence and risk factors for post-operative delirium in patients undergoing thoracotomy. Specifically, the study will assess if there is any relationship between an intra-operative decrease in brain oxygen levels which can occur during one-lung ventilation, and the occurrence of delirium in the post-operative period.

Clinical Trial Description

This will be a prospective, observational study on 200 patients. Consenting thoracic surgical patients presenting for open thoracotomy or VATS will be assessed pre-operatively for baseline cognitive status and clinically relevant risk factors for delirium. Intra-operatively, patients will undergo cerebral oxygenation monitoring using near infra-red spectroscopy cerebral oximetry. Postoperatively, patients will be assessed twice daily for the presence or absence of delirium using the Confusion Assessment Methodology (CAM) scoring system during their hospital stay.

A clinically relevant desaturation will be defined as a 25% decrease from the patient's baseline saturation, which will be determined while the patient is breathing room air pre-operatively. The severity and duration of any desaturation will be recorded and subsequently analyzed for correlation with post-operative delirium. Bivariate associations between the risk of delirium and predictor variables will be sought. If appropriate, logistic regression models will be constructed with the outcome of delirium.

Significance: Previous studies at our centre have resulted in over 35% of thoracic surgical patients developing significant, intra-operative cerebral desaturation. We propose to study a convenience sample of 200 consecutive patients. Depending on the relative risk of developing delirium with a significant cerebral desaturation, this study may be adequately powered to determine the associated risk of delirium. This study will provide background information in planning further interventional trials to prevent desaturation and possibly reduce the incidence of delirium, as well as aid in the planning of larger multi-center trials to more accurately assess the risk of intra-operative decreases in cerebral oxygenation and the role this event contributes to the occurrence of delirium. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03165539
Study type	Observational
Source	University of Manitoba
Contact	Stephen E Kowalski, MD
Phone	204-787-1414
Email	sekowalski@hsc.mb.ca
Status	Recruiting
Phase
Start date	September 2015
Completion date	February 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04551508` - Delirium Screening 3 Methods Study
Recruiting	`NCT05891873` - Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Recruiting	`NCT04792983` - Cognition and the Immunology of Postoperative Outcomes
Recruiting	`NCT06194474` - Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
Completed	`NCT03095417` - Improving the Recovery and Outcome Every Day After the ICU	N/A
Completed	`NCT05395559` - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Terminated	`NCT03337282` - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Not yet recruiting	`NCT04846023` - Pediatric Delirium Screening in the PICU Via EEG	N/A
Not yet recruiting	`NCT04538469` - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting	`NCT03807388` - ReMindCare App for Patients From First Episode of Psychosis Unit.	N/A
Withdrawn	`NCT02673450` - PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
Recruiting	`NCT03256500` - Transcranial Direct Current Stimulation for the Treatment of Delirium	N/A
Not yet recruiting	`NCT02892968` - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients	N/A
Completed	`NCT02890927` - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital	N/A
Completed	`NCT02518646` - DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models	N/A
Completed	`NCT02554253` - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction	Phase 2
Recruiting	`NCT02305589` - The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium	N/A
Completed	`NCT02628925` - Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale	N/A
Completed	`NCT02213900` - Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms