Clinical trial NCT04371029: Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS
Official title: Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
COVID-19
Keywords: Neck inspiratory muscle (=NIM)
Sleep
Intensive care unit
ARDS
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Proportion of patients with altered spleep
timeFrame: At day 10 after inclusion
Secondary outcomes:
measure: Sleep architecture at hospital discharge
timeFrame: At day 28 after inclusion
measure: Sleep monitoring during hospital stay after ICU discharge
timeFrame: At day 18 after ICU discharge
measure: Sleep quality
timeFrame: 3 months after hospiotal discharge
measure: Sleep architecture at month-3
timeFrame: 3 months after hospital discharge
measure: Cost of ICU hospitalization
timeFrame: From inclusion to ICU discharge, up to 10 days after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
Study officials:
References: