Cerebral SaturationNIRS-1NCT03107260
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.
A study testing To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients in people with Cerebral Saturation and Cognitive Impairment, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cerebral Saturation, Cognitive Impairment, Emergencies
- What is being tested?
- To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2016to 23 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Saturation, Cognitive Impairment, Emergencies
- Being tested
- To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients
- Medical subject headings
- Cognitive Dysfunction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patientsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Occurrence of postoperative cognitive dysfunction | Other | Not described Receives: Other: To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of POCD
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start15 Jan 2016
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral SaturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107260
- Sponsor's protocol ID
- PI2015_843_0018
- Acronym
- NIRS-1
- Status last verified
- Jun 2026
- First submitted
- 5 Apr 2017
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03107260
- Acronym / sponsor ID
- NIRS-1 / PI2015_843_0018
- Conditions
- Cerebral Saturation, Cognitive Impairment, Emergencies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occurrence of postoperative cognitive dysfunction | Other | Other: To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 65 years
- Non-cardiac, thoracic and vascular emergency surgery
- Surgery under general anesthesia
- ASA I, II or III
- Simple information without consent
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patientsEvaluate 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 | Other | Occurrence of postoperative cognitive dysfunction |
Primary outcome
Occurrence of POCD
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients in people with Cerebral Saturation and Cognitive Impairment, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of POCD (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.