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Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

Micro-sleep During Maintenance Wakefulness Tests

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04559269
Enrollment
98
Registered
2020-09-22
Start date
2019-10-01
Completion date
2021-12-31
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatectomy, Lobectomy, Pancreaticoduodenectomy

Keywords

Maintenance Wakefulness Tests, micro-sleep, sleepiness, latency, EEG

Brief summary

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

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

Interventions

OTHERNo intervention

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TThe primary endpoint was to determine if LepMAP was better than ΔMAP for the prediction of hypotensive event at 1, 2 and 5 minutes, defined as a mean arterial pressure of less than 65 mmHgOnly during perioperative periodthe number of patients with MS during MWT as well as the mean number of MS per patient will be measured

Countries

France

Contacts

Primary Contactlaure Peter-Derex
laure.peter-derex@chu-lyon.fr4 72 07 19 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026