Abdominal Muscle Thickness in Mechanically Ventilated Patients

NCT ID: NCT03567564

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-26

Study Completion Date

2019-12-28

Brief Summary

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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

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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.

Conditions

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Muscle Weakness Weaning Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mechanically ventilated patients

Abdominal muscles ultrasound

Abdominal muscles ultrasound

Intervention Type DIAGNOSTIC_TEST

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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Piva Simone

Dr. Piva Simone, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simone Piva, M.D.

Role: STUDY_DIRECTOR

University Of Brescia, Spedali Civili di Brescia

Ewan Goligher, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Toronto General Hospital Research Institute

Toronto, , Canada

Site Status

Spedali Civili di Brescia

Brescia, , Italy

Site Status

Countries

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Canada Italy

References

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Schreiber AF, Bertoni M, Coiffard B, Fard S, Wong J, Reid WD, Brochard LJ, Piva S, Goligher EC. Abdominal Muscle Use During Spontaneous Breathing and Cough in Patients Who Are Mechanically Ventilated: A Bi-center Ultrasound Study. Chest. 2021 Oct;160(4):1316-1325. doi: 10.1016/j.chest.2021.05.053. Epub 2021 Jun 6.

Reference Type DERIVED
PMID: 34090872 (View on PubMed)

Other Identifiers

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Abdominals

Identifier Type: -

Identifier Source: org_study_id

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