search
Back to results

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)

Primary Purpose

Cerebral Saturation, Cognitive Impairment, Emergencies

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Saturation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU Amiens PicardieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Occurrence of postoperative cognitive dysfunction

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of POCD

Secondary Outcome Measures

Full Information

First Posted
April 5, 2017
Last Updated
April 5, 2017
Sponsor
Centre Hospitalier Universitaire, Amiens
search

1. Study Identification

Unique Protocol Identification Number
NCT03107260
Brief Title
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.
Acronym
NIRS-1
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
July 13, 2018 (Anticipated)
Study Completion Date
July 13, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Saturation, Cognitive Impairment, Emergencies

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Occurrence of postoperative cognitive dysfunction
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients
Intervention Description
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
Primary Outcome Measure Information:
Title
Occurrence of POCD
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre NTOUBA, Dr
Phone
+33322668370
Email
ntouba.alexandre@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre NTOUBA, Dr
Phone
+33322668370
Email
ntouba.alexandre@chu-amiens.fr

12. IPD Sharing Statement

Learn more about this trial

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.

We'll reach out to this number within 24 hrs