Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

NCT04559269 | Unknown

• 1 other identifier: 2020_Microsleep1
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Lobectomy; Hepatectomy; Pancreaticoduodenectomy

Keywords

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

Outcome Measures

Primary Outcomes (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

  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

Study Arms (1)

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

Interventions

No intervention OTHER

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

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse / GHN

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Sleepiness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

laure Peter-Derex

CONTACT

4 72 07 19 29; laure.peter-derex@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: September 22, 2020
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: September 22, 2020

Record last verified: 2020-07

Locations

FR (1)