Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

• Conditions: Lobectomy; Hepatectomy; Pancreaticoduodenectomy
• Interventions: Other: No intervention

• Registration Number: NCT04559269
• Lead Sponsor: Hospices Civils de Lyon

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

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	No intervention	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.

Primary Outcome Measures

Name	Time	Method
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 mmHg	Only during perioperative period	the number of patients with MS during MWT as well as the mean number of MS per patient will be measured

Trial Locations

Locations (1)

Hôpital de la Croix Rousse / GHN; 🇫🇷 Lyon, France