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

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).

Study Overview

• Status: Completed
• Conditions: COVID-19; ARDS
• Intervention / Treatment: Other: PSG

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).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Hôpital Pellegrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep architecture at hospital discharge	Thanks to a PSG the night befor discharge, the seep architecture will be estimated.	At day 28 after inclusion
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
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
Sleep architecture at month-3	Thanks to a PSG at 3 months, the seep architecture will be estimated.	3 months after hospital discharge
Cost of ICU hospitalization	all cost will be estimated during ICU hospitalization.	From inclusion to ICU discharge, up to 10 days after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2020
• Primary Completion (ACTUAL): September 9, 2020
• Study Completion (ACTUAL): December 9, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (ACTUAL): May 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Sleep; ARDS; Intensive care unit; Neck inspiratory muscle (=NIM)
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Aspiration
• Other Study ID Numbers: CHUBX 2020/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No