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Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Unknown

Conditions

Hepatectomy
Pancreaticoduodenectomy
Lobectomy

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04559269
2020_Microsleep1

Details and patient eligibility

About

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.

Full description

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

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

98 participants in 1 patient group

Cohort 1
Description:
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.
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

laure Peter-Derex

Data sourced from clinicaltrials.gov

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