Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

NCT ID: NCT04559269

Last Updated: 2020-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-12-31

Brief Summary

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During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) \< 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

Detailed Description

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Hypothesis : the area under the ROC curves (ROC AUCs) at 1, 2 and 5 minutes of LepMAP would be superior to AMAP

Conditions

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Lobectomy Hepatectomy Pancreaticoduodenectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

Cohort of 98 patients suffering from sleep disorders hospitalized between September 2017 and January 2019 in the Sleep Medicine Center of the Croix Rousse Hospital (Lyon) for objective sleepiness evaluation with polysomnography and MWT.

No intervention

Intervention Type OTHER

patients have benefited from maintenance wakefulness tests as part of their clinical evaluation

Interventions

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No intervention

patients have benefited from maintenance wakefulness tests as part of their clinical evaluation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and MWT, in order to evaluate their sleepiness (usually before they resume driving)
* hospitalized in the Center for Sleep Medicine (Hôpital Lyon Croix Rousse) between September 2017 and January 2019

Exclusion Criteria

* patient with active encephalopathy or epilepsy whose EEG was abnormal
* denial of study participation
* availability of all the recordings (n=4 tests) of the MWT
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital de la Croix Rousse / GHN

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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laure Peter-Derex

Role: CONTACT

4 72 07 19 29 ext. +33

Facility Contacts

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Laure Peter-Derex

Role: primary

Other Identifiers

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2020_Microsleep1

Identifier Type: -

Identifier Source: org_study_id

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