LobectomyNCT04559269
Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests
An observational study of Lobectomy and Hepatectomy, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lobectomy, Hepatectomy, Pancreaticoduodenectomy
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and wakefulness tests, generally with a view to authorizing driving.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Croix Rousse / GHN
Lyon, 69004
Laure Peter-Derex
About this study
Official title: 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.
Read the detailed description
Hypothesis : the area under the ROC curves (ROC AUCs) at 1, 2 and 5 minutes of LepMAP would be superior to AMAP
- Conditions
- Lobectomy, Hepatectomy, Pancreaticoduodenectomy
- Being tested
- No intervention
- Keywords
- Maintenance Wakefulness Tests, micro-sleep, sleepiness, latency, EEG
- Medical subject headings
- Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
patients have benefited from maintenance wakefulness tests as part of their clinical evaluation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Only during perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Oct 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LobectomyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559269
- Sponsor's protocol ID
- 2020_Microsleep1
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-sleep During Maintenance Wakefulness Tests
- ClinicalTrials.gov ID
- NCT04559269
- Acronym / sponsor ID
- 2020_Microsleep1
- Conditions
- Lobectomy, Hepatectomy, Pancreaticoduodenectomy
- Keywords
- Maintenance Wakefulness Tests, micro-sleep, sleepiness, latency, EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No interventionCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and wakefulness tests, generally with a view to authorizing driving.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionpatients have benefited from maintenance wakefulness tests as part of their clinical evaluation | Other | Cohort 1 |
Primary outcome
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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lobectomy and Hepatectomy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact laure Peter-Derex (4 72 07 19 29 ext. +33, laure.peter-derex@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Only during perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020; AzTrials last refreshed its copy on 27 Oct 2026.