Abdominal Muscle Thickness in Mechanically Ventilated Patients

Muscle Weakness Clinical Trial

Official title:

Abdominal Muscle Thickness in Mechanically Ventilated Patients During Spontaneous Breathing Trials

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03567564
• Other study ID #: Abdominals
• Status: Enrolling by invitation
• Start date: April 26, 2017
• Est. completion date: December 28, 2019

Study information

• Verified date: June 2018
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: December 28, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Weaning Failure

Intervention

Diagnostic Test:
• Abdominal muscles ultrasound
Abdominal muscles ultrasound during a spontaneous breathing trial using the M-mode to calculate the thickening fraction of the anterior and lateral abdominal muscles under multiple circumstances (tasks performed by the patients)

Locations

Country	Name	City	State
Canada	Toronto General Hospital Research Institute	Toronto
Italy	Spedali Civili di Brescia	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia	University of Toronto

Countries where clinical trial is conducted

Canada,  Italy, 

Outcome

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