The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery. (NIRS-1)

There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies.

Age is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 65 years
  • Non-cardiac, thoracic and vascular emergency surgery
  • Surgery under general anesthesia
  • ASA I, II or III
  • Simple information without consent
  • Patient affiliated to social security

Exclusion Criteria:

  • Inability to understand
  • Patient under tutelage, or curatorship or deprived of public right
  • ASA IV
  • History of severe dementia MMSE <20
  • Personal or familial history of malignant hyperthermia
  • History of allergy or hypersensitivity to anesthetic products used
  • Contra-indication to Cisatracurium®: myasthenia gravis
  • Contra-indication to Sevoflurane®
  • Contra-indication to local anesthetics
  • Indication of use of a Ketamine®-type hypnotic (modification of the BIS)
  • Indication of use of nitrous oxide
  • History of cranial trauma
  • Neuromuscular pathology
  • Spinal anesthesia
  • Cardiac, thoracic or vascular surgery
  • Surgery not performed in emergency
  • Neurochirugia in the context of cranial trauma
  • Any surgery that does not allow the use of the NIRS (impossibility of positioning of the electrodes by the location of the surgical field).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Occurrence of postoperative cognitive dysfunction
Evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in non-cardiac, thoracic and vascular emergency surgery in patients 65 years of age and older. The occurrence of POCD will be defined by the MMSE decrease of at least 4 points at 24, 48 or 72 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of POCD
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2016

Primary Completion (Anticipated)

July 13, 2018

Study Completion (Anticipated)

July 13, 2018

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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