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

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

Study Overview

• Status: Recruiting
• Conditions: Weaning From Mechanical Ventilation; Parasternal Intercostal Muscle Thickness
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Wesameldin A Soltan, M.D.; Phone Number: 0020101012215; Email: wesamsultan1@gmail.com

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32511
      • Recruiting
      • Faculty of Medicine - Menoufia University
      • Contact: Muhammad A AlGhorayeb, MD; Phone Number: +201000203165; Email: drmsebaey@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the thickness fraction of the parasternal intercostal muscle as a predictor of successful spontaneous breathing trials	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.	Before the start spontaneous breathing trial

Collaborators and Investigators

• Sponsor: Wesameldin Abelrahman Soltan
• Investigators: Study Director: Wesameldin A Soltan, M.D., Faculty of Medicine, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: mechanical ventilation, parasternal muscle thickness
• Other Study ID Numbers: Parasternal Intercostals US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No