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
About this trial
This is an interventional other trial for Cerebral Saturation
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).
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
NCT ID
NCT03107260
First Posted
April 5, 2017
Last Updated
April 5, 2017
Sponsor
Centre Hospitalier Universitaire, Amiens
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.
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