Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

Hepatectomy Clinical Trial

Official title:

Micro-sleep During Maintenance Wakefulness Tests

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559269
• Other study ID #: 2020_Microsleep1
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: laure Peter-Derex
• Phone: 4 72 07 19 29
• Email: laure.peter-derex[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatectomy
• Lobectomy
• Pancreaticoduodenectomy

Intervention

Other:
• No intervention
patients have benefited from maintenance wakefulness tests as part of their clinical evaluation

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse / GHN	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TThe primary endpoint was to determine if LepMAP was better than ?MAP 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