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Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS (COVISLEEP)

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ClinicalTrials.gov Identifier: NCT04371029
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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).

Condition or disease Intervention/treatment Phase
ARDS COVID-19 Other: PSG Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : December 28, 2020

Arm Intervention/treatment
Experimental: Experimental
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.
Other: PSG
Polysomnography at 3 times, actimetry measure and Pittsburgh questionnaire




Primary Outcome Measures :
  1. Proportion of patients with altered spleep [ Time Frame: At day 10 after inclusion ]
    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 :
  1. Sleep architecture at hospital discharge [ Time Frame: At day 28 after inclusion ]
    Thanks to a PSG the night befor discharge, the seep architecture will be estimated.

  2. Sleep monitoring during hospital stay after ICU discharge [ Time Frame: At day 18 after ICU discharge ]
    Thanks to actimetry measure during hospitalization in the post ICU ward.

  3. Sleep quality [ Time Frame: 3 months after hospiotal discharge ]
    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.

  4. Sleep architecture at month-3 [ Time Frame: 3 months after hospital discharge ]
    Thanks to a PSG at 3 months, the seep architecture will be estimated.

  5. Cost of ICU hospitalization [ Time Frame: From inclusion to ICU discharge, up to 10 days after inclusion ]
    all cost will be estimated during ICU hospitalization.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371029


Contacts
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Contact: Renaud PREVEL, Dr 5 56 79 55 17 ext +33 renaud.prevel@chu-bordeaux.fr
Contact: Léo GRASSION, Dr 5 57 65 63 38 ext +33 leo.grassion@chu-bordeaux.fr

Locations
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France
Hopital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Renaud PREVEL, Dr    5 56 79 55 17 ext +33    renaud.prevel@chu-bordeaux.fr   
Contact: Léo GRASSION, Dr    5 57 65 63 38 ext +33    leo.grassion@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04371029    
Other Study ID Numbers: CHUBX 2020/14
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Neck inspiratory muscle (=NIM)
Sleep
Intensive care unit
ARDS
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes