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

NCT04371029 | Completed

• 1 other identifier: CHUBX 2020/14
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

ARDS; COVID-19

Keywords

Neck inspiratory muscle (=NIM); Sleep; Intensive care unit; ARDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Sleep architecture at hospital discharge

  At day 28 after inclusion

• Sleep monitoring during hospital stay after ICU discharge

  At day 18 after ICU discharge

• Sleep quality

  3 months after hospiotal discharge

• Sleep architecture at month-3

  3 months after hospital discharge

• Cost of ICU hospitalization

  From inclusion to ICU discharge, up to 10 days after inclusion

Study Arms (1)

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

Interventions

PSG OTHER

Polysomnography at 3 times, actimetry measure and Pittsburgh questionnaire

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Guardianship or curatorship
• Prisoners
• No health insurance
• Pregnancy

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hopital Pellegrin

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: April 28, 2020
• Primary Completion: September 9, 2020
• Study Completion: December 9, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)