Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04559269
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lobectomy; Hepatectomy; Pancreaticoduodenectomy	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 Design

• Study Type: Observational
• Anticipated Enrollment: 98 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Micro-sleep During Maintenance Wakefulness Tests
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital de la Croix Rousse / GHN	Lyon		France	69004

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04559269
• Other Study ID Numbers: 2020_Microsleep1
• First Posted: Sep 22, 2020
• Last Update Posted: Sep 22, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: Maintenance Wakefulness Tests; micro-sleep; sleepiness; latency; EEG

Study Results

No Results Posted as of Sep 22, 2020