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

COVID-19 Clinical Trial

— COVISLEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371029
• Other study ID #: CHUBX 2020/14
• Status: Completed
• Phase: N/A
• Start date: April 28, 2020
• Est. completion date: December 9, 2020

Study information

• Verified date: June 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Respiratory Aspiration

Intervention

Other:
• PSG
Polysomnography at 3 times, actimetry measure and Pittsburgh questionnaire

Locations

Country	Name	City	State
France	Hopital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At day 10 after inclusion
Secondary	Sleep architecture at hospital discharge	Thanks to a PSG the night befor discharge, the seep architecture will be estimated.	At day 28 after inclusion
Secondary	Sleep monitoring during hospital stay after ICU discharge	Thanks to actimetry measure during hospitalization in the post ICU ward.	At day 18 after ICU discharge
Secondary	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.	3 months after hospiotal discharge
Secondary	Sleep architecture at month-3	Thanks to a PSG at 3 months, the seep architecture will be estimated.	3 months after hospital discharge
Secondary	Cost of ICU hospitalization	all cost will be estimated during ICU hospitalization.	From inclusion to ICU discharge, up to 10 days after inclusion