Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS (COVISLEEP)
Primary Purpose
ARDS, COVID-19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PSG
Sponsored by
About this trial
This is an interventional other trial for ARDS focused on measuring Neck inspiratory muscle (=NIM), Sleep, Intensive care unit, ARDS
Eligibility Criteria
Inclusion Criteria:
- Patient above 18 year-old admitted to intensive care unit
- COVID-19 assessed by PCR on nasopharyngeal swab or pulmonary sample
- Oro-tracheal intubation for mechanical ventilation
Exclusion Criteria:
- Guardianship or curatorship
- Prisoners
- No health insurance
- Pregnancy
Sites / Locations
- Hopital Pellegrin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
A Polysomnography (PSG) will be performed in all patient the night before extubation, the day prior discharge and 3 month after. Recording will consist in EEG, EOG et EMG of the chin. We will record NIM EMG. We will also performed an actimetry during hospitalization in the post ICU ward. A quality of sleep questionnaire (Pittsburgh questionnaire) will be completed by the patients during the visit at 3 month.
Outcomes
Primary Outcome Measures
Proportion of patients with altered spleep
Comparison between patients with NIM activation during the night and patients without NIM activation during the night, in patients COVID 19 ARDS with altered spleep. A Polysomnography (PSG) will be performed the night before extubation.
Secondary Outcome Measures
Sleep architecture at hospital discharge
Thanks to a PSG the night befor discharge, the seep architecture will be estimated.
Sleep monitoring during hospital stay after ICU discharge
Thanks to actimetry measure during hospitalization in the post ICU ward.
Sleep quality
Sleep quality will be evaluate by the Pittsburgh sleep quality index. The 7 components of the score add up for give an overall score ranging from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.
Sleep architecture at month-3
Thanks to a PSG at 3 months, the seep architecture will be estimated.
Cost of ICU hospitalization
all cost will be estimated during ICU hospitalization.
Full Information
NCT ID
NCT04371029
First Posted
April 28, 2020
Last Updated
June 4, 2021
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04371029
Brief Title
Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS
Acronym
COVISLEEP
Official Title
Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Most patients in intensive care units (ICUs) experience severe sleep disruption. Sleep disruption and sleep alteration may have an influence on the ability to breathe spontaneously. But, the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Therefore, the aim of this study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).
Detailed Description
Sleep alteration is a common problem among ventilated ICU patient. About one third of the patient have abnormal EEG pattern which cannot be scored by using the AASM standard criteria. Patients experience marked fragmentation, absence of deep sleep, and REM sleep is decreased, . It has been shown that sleep deprivation has a negative impact on respiratory muscle endurance. So a good sleep is essential when the respiratory system is being challenged, as in the ICU during the weaning period. Indeed, in the ICU, patients with altered sleep, had a markedly longer weaning duration than in patients with normal sleep, and are more likely to fail a spontaneous breathing trial. Many factors may influence the quality of sleep in the ICU (noise, medication, mechanical ventilation …) but few studies have focus on the cause of this altered sleep, and the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Mechanical ventilation can decrease the charge imposed on the respiratory pump, and allows muscle to rest. Indeed, when the charge is too high (for example after an ARDS during the weaning period), the diaphragm may be overloaded, and there could be a greater involvement of other inspiratory muscles in breathing. In other pathological condition, the neck inspiratory muscle activity is increased (e.g. COPD, amyotrophic lateral sclerosis), and sometimes this activity persist during sleep with marked degradation in sleep architecture. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Ttherefore, the aim of tis study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, COVID-19
Keywords
Neck inspiratory muscle (=NIM), Sleep, Intensive care unit, ARDS
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
A Polysomnography (PSG) will be performed in all patient the night before extubation, the day prior discharge and 3 month after. Recording will consist in EEG, EOG et EMG of the chin. We will record NIM EMG. We will also performed an actimetry during hospitalization in the post ICU ward. A quality of sleep questionnaire (Pittsburgh questionnaire) will be completed by the patients during the visit at 3 month.
Intervention Type
Other
Intervention Name(s)
PSG
Intervention Description
Polysomnography at 3 times, actimetry measure and Pittsburgh questionnaire
Primary Outcome Measure Information:
Title
Proportion of patients with altered spleep
Description
Comparison between patients with NIM activation during the night and patients without NIM activation during the night, in patients COVID 19 ARDS with altered spleep. A Polysomnography (PSG) will be performed the night before extubation.
Time Frame
At day 10 after inclusion
Secondary Outcome Measure Information:
Title
Sleep architecture at hospital discharge
Description
Thanks to a PSG the night befor discharge, the seep architecture will be estimated.
Time Frame
At day 28 after inclusion
Title
Sleep monitoring during hospital stay after ICU discharge
Description
Thanks to actimetry measure during hospitalization in the post ICU ward.
Time Frame
At day 18 after ICU discharge
Title
Sleep quality
Description
Sleep quality will be evaluate by the Pittsburgh sleep quality index. The 7 components of the score add up for give an overall score ranging from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.
Time Frame
3 months after hospiotal discharge
Title
Sleep architecture at month-3
Description
Thanks to a PSG at 3 months, the seep architecture will be estimated.
Time Frame
3 months after hospital discharge
Title
Cost of ICU hospitalization
Description
all cost will be estimated during ICU hospitalization.
Time Frame
From inclusion to ICU discharge, up to 10 days after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient above 18 year-old admitted to intensive care unit
COVID-19 assessed by PCR on nasopharyngeal swab or pulmonary sample
Oro-tracheal intubation for mechanical ventilation
Exclusion Criteria:
Guardianship or curatorship
Prisoners
No health insurance
Pregnancy
Facility Information:
Facility Name
Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS
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