Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

Micro-sleep During Maintenance Wakefulness Tests

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.

Study Overview

• Status: Unknown
• Conditions: Hepatectomy; Lobectomy; Pancreaticoduodenectomy
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Anticipated): 98

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hôpital de la Croix Rousse / GHN
    • Contact: Laure Peter-Derex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and wakefulness tests, generally with a view to authorizing driving.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention; patients have benefited from maintenance wakefulness tests as part of their clinical evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	the number of patients with MS during MWT as well as the mean number of MS per patient will be measured	Only during perioperative period

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: EEG; latency; sleepiness; Maintenance Wakefulness Tests; micro-sleep
• Other Study ID Numbers: 2020_Microsleep1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No