Abdominal Muscle Thickness in Mechanically Ventilated Patients

• Conditions: Muscle Weakness; Weaning Failure
• Interventions: Diagnostic Test: Abdominal muscles ultrasound

• Registration Number: NCT03567564
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary

The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.

Detailed Description

The purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. In addition the reliability of the sonographic measurements will be assessed.

Study Timeline

• Study Start: 2017-04-26
• Status Verified: 2018-06
• Study First Submitted: 2018-06-02
• Study First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-22
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Primary Completion: 2019-05-30
• Study Completion: 2019-12-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• greater than 18 years old
• Patients requiring invasive mechanical ventilation including patients with endotracheal tube and tracheotomies

Exclusion Criteria

• Patients with a previously diagnosed neuromuscular disorder (acute or chronic)
• Behavioural agitation
• Patients who are not awake and cooperative
• Previously enrolled in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanically ventilated patients	Abdominal muscles ultrasound	Abdominal muscles ultrasound

Primary Outcome Measures

Name	Time	Method
Correlation between thickening fraction and SBT outcome	Measurements will be performed before SBT	Correlation between thickening fraction of each muscles evaluated by ultrasound before the SBT and the SBT outcome.

Secondary Outcome Measures

Name	Time	Method
Correlation between the pressures generated by respiratory muscles and SBT outcome	Measurements will be performed before SBT	Correlation between the pressures generated by respiratory muscles during the ultrasound measurements (Twice Transdiaphragmatic pressure, TwPdi; maximal inspiratory pressure, MIP) and SBT outcome
Inter-rater agreement	Measurements will be performed before SBT	Concordance of measurements of abdominal muscle thickness and thickening fraction in mechanically ventilated patients performed by two different observers will be evaluated.

Trial Locations

Locations (2)

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Toronto General Hospital Research Institute; 🇨🇦 Toronto, Canada