Role of Ultrasound Assessment of Parasternal Intercostal Muscle Thickness During Weaning From Mechanical Ventilation

Sponsor

Wesameldin Abelrahman Soltan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04779463

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessment of the the parasternal intercostal muscles thickness by the ultrasonography as a weaning predictor of the mechanically ventilated patients

Condition or Disease	Intervention/Treatment	Phase
Parasternal Intercostal Muscle Thickness Weaning From Mechanical Ventilation	Diagnostic Test: Parasternal intercostal muscles thickness ultrasound indicies

Detailed Description

impact of parasternal muscle thickness on the weaning process of the mechanically ventilated patients in ICU

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Role of Ultrasound Assessment of Parasternal Intercostal Muscle Thickness During Weaning From Mechanical Ventilation

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Mechanical Ventilated patients All patients are invasively mechanically ventilated at least 24 hours, and are clinically stable as ready to undergo a spontaneous breathing trial.	Diagnostic Test: Parasternal intercostal muscles thickness ultrasound indicies Parasternal intercostal muscles thickness ultrasound indicies includes: Parasternal Intercostals Thickness Fraction. Parasternal Intercostals Thickness at the End of Inspiration. Parasternal Intercostals thickness at the End of Expiration. Other Names: Diaphragmatic thickness

Arm

Intervention/Treatment

Mechanical Ventilated patients

All patients are invasively mechanically ventilated at least 24 hours, and are clinically stable as ready to undergo a spontaneous breathing trial.

Diagnostic Test: Parasternal intercostal muscles thickness ultrasound indicies

Parasternal intercostal muscles thickness ultrasound indicies includes: Parasternal Intercostals Thickness Fraction. Parasternal Intercostals Thickness at the End of Inspiration. Parasternal Intercostals thickness at the End of Expiration.

Other Names:

Diaphragmatic thickness

Outcome Measures

Primary Outcome Measures

the thickness fraction of the parasternal intercostal muscle as a predictor of successful spontaneous breathing trials [Before the start spontaneous breathing trial]
The primary outcome is to assess the change of the parasternal intercostal muscles thickness at end of expiration and end of inspiration to verify the thickness fraction of the parasternal intercostal muscle as a predictor of successful spontaneous breathing trials.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any patient invasively mechanically ventilated at least 24 hours on a pressure support mode who is clinically stable and ready to undergo a spontaneous breathing trial.

All patients will be:

Alert.
Afebrile.
Adequate cough with absence of excessive tracheobronchial secretion.
Fraction of inspired oxygen (FIO2) of <50%.
PEEP ≤8 cmH2O.
PaO2/FiO2 > 150.
pH ≥7.35 and ≤7.45.
Respiratory rate (RR) ≤35 breaths/min.
Hemodynamically stable in the absence of vasopressors.
Stable metabolic and endocrinal status.
Euglycemic state.
Adequate mentation (no sedation or stable neurologic patient).

Exclusion Criteria:

Diaphragmatic paralysis (detected by ultrasonography).Patients&Methods. 6

Pregnant women.
Age: >= 18 years.
Surgical dressings over measurement point which would preclude ultrasound exam.
Underweight patients (Body mass index <18.5 kg/m2).
Morbidly obese patient (Body mass index ≥ 40 kg/m2).
Primary neuro-muscular diseases.
Central coditions with depressed central respiratory drive (encephalitis, and brainstem haemorrhage/ischaemia).
Repiratory conditions with reduced pulmonary compliance (interstitial lung disease, pulmonary hemorrhage, and diffuse pulmonary infiltrates) or reduced chest wall compliance (kyphoscoliosis).
Cardiac conditions with high risk of weaning induced pulmonary edema (congestive heart failure, cyanotic heart diease, pulmonary hypertension, and ischemic heart diease).
Addict patients.
Patients with psychiatric disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine - Menoufia University	Shibīn Al Kawm	Menoufia	Egypt	32511

Sponsors and Collaborators

Wesameldin Abelrahman Soltan

Investigators

Study Director: Wesameldin A Soltan, M.D., faculty of medicine, Menoufia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wesameldin Abelrahman Soltan, Associate Professor, Menoufia University

ClinicalTrials.gov Identifier:

NCT04779463

Other Study ID Numbers:

Parasternal Intercostals US

First Posted:

Mar 3, 2021

Last Update Posted:

Mar 3, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wesameldin Abelrahman Soltan, Associate Professor, Menoufia University

mechanical ventilation, parasternal muscle thickness

Study Results

No Results Posted as of Mar 3, 2021