MedDataX Logo

Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion

NCT ID: NCT07143695

Last Updated: 2025-09-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Increased days of MV are not without hazards, including barotraumas and ventilator-associated pneumonia. Similarly, premature separation of MV is associated with increased mortality secondary to adverse cardiorespiratory events. Therefore, the time of weaning should be wisely evaluated. There is growing evidence concerning respiratory muscles dysfunction that contributes to difficulty or prolonged liberation from MV.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Temporal Change in Parasternal Thickening Fraction as a Predictor for Weaning

NCT07083128

Mechanical Ventilation Weaning From Mechanical Ventilation Weaning Failure
RECRUITING

Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation

NCT05846945

Respiratory Failure
COMPLETED NA

Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning

NCT06465082

Weaning From Mechanical Ventilation
RECRUITING

Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients

NCT00538746

Acute Respiratory Failure
UNKNOWN NA

Inspiratory Muscle Training in Difficult to Wean Patients

NCT03240263

Weaning Failure
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Researchers aim to evaluate the influence of adding parasternal thickening fraction to the standard weaning criteria and its impact on reintubation

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critically Ill

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

patients in control will be weaning using standard criteria

Group Type SHAM_COMPARATOR

Sham parasternal intercostal thickening

Intervention Type DEVICE

Ultrasound assessment only for purpose of blinding

Ultrasound

patient in this group will be weaned using standard criteria plus mean parasternal thickening fraction less than 6.5 %

Group Type ACTIVE_COMPARATOR

Parasternal intercostal thickening fraction

Intervention Type DEVICE

Parasternal intercostal thickening fraction less than 6.5%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parasternal intercostal thickening fraction

Parasternal intercostal thickening fraction less than 6.5%

Intervention Type DEVICE

Sham parasternal intercostal thickening

Ultrasound assessment only for purpose of blinding

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* critically ill patient mechanically ventilated for 24 hours or more first spontaneous breathing trial

Exclusion Criteria

* patient refusal difficult ultrasound views tracheostomized patient neuromuscular disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mina Adolf Helmy

Lecturer of anesthesia and critical care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Cairo, Giza Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cairo university

Role: CONTACT

[email protected]
+201275716942

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mina Helmy

Role: primary

[email protected]
01275716942

References

Explore related publications, articles, or registry entries linked to this study.

Helmy MA, Hasanin A, Milad LM, Mostafa M, Fathy S. Parasternal intercostal muscle thickening as a predictor of non-invasive ventilation failure in patients with COVID-19. Anaesth Crit Care Pain Med. 2022 Jun;41(3):101063. doi: 10.1016/j.accpm.2022.101063. Epub 2022 Apr 26. No abstract available.

Reference Type BACKGROUND
PMID: 35487407 (View on PubMed)

Helmy MA, Milad LM, Hasanin AM, Mostafa M, Mannaa AH, Youssef MM, Abdelaziz M, Alkonaiesy R, Elshal MM, Hosny O. Parasternal intercostal thickening at hospital admission: a promising indicator for mechanical ventilation risk in subjects with severe COVID-19. J Clin Monit Comput. 2023 Oct;37(5):1287-1293. doi: 10.1007/s10877-023-00989-4. Epub 2023 Mar 24.

Reference Type BACKGROUND
PMID: 36961635 (View on PubMed)

Helmy MA, Hasanin A, Milad LM, Mostafa M, Hamimy WI, Muhareb RS, Raafat H. Ability of parasternal intercostal muscle thickening fraction to predict reintubation in surgical patients with sepsis. BMC Anesthesiol. 2024 Aug 22;24(1):294. doi: 10.1186/s12871-024-02666-8.

Reference Type BACKGROUND
PMID: 39174907 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PIC criterion

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Parasternal Intercostal Ultrasound vs RSBI for Weaning Prediction
NCT07144878 COMPLETED NA
Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU
NCT04658498 RECRUITING NA
The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients.
NCT06095609 COMPLETED NA
Ultrasound-Guided Diaphragmatic Thickness Assessment as an Indicator of Successful Extubation in Mechanically Ventilated
NCT03894436 COMPLETED
Comparison of Weaning Parameters and Diaphragm Thickness Changes
NCT06967623 COMPLETED
Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients
NCT01867853 COMPLETED
NMES to Prevent Respiratory Muscle Atrophy in Mechanically Ventilated Patients
NCT03453944 UNKNOWN NA
Variability Analysis During Weaning and Extubation in Critically Ill Patients
NCT01800448 COMPLETED
Protocolized Ventilator Weaning Verses Usual Care
NCT03724643 COMPLETED NA
The Role of Diaphragmatic Ultrasound as a Predictor of Extubation From Mechanical Ventilation
NCT05063526 COMPLETED
Changes of Weaning Parameter in Weaning Failure Patient After Tracheostomy as a Predictor of Subsequent Weaning
NCT01312142 UNKNOWN
Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome
NCT04825509 COMPLETED
Comparison of Two Different Types of Mechanical Ventilation Weaning in Patients in the ICU
NCT02122016 COMPLETED PHASE4
Effect of Lung Volume Recruitment Technique After Extubation
NCT05128552 COMPLETED NA
Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning
NCT00606788 SUSPENDED NA
Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
NCT06499389 RECRUITING NA
Assessing Diaphragm Muscle Inactivity in Mechanically Ventilated ICU Patients
NCT02434016 COMPLETED
Post Extubation Chest Physiotherapy in ICU
NCT01967108 COMPLETED NA
ATC vs PSV for Weaning in Patients With Respiratory Failure
NCT07238140 COMPLETED NA
Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction
NCT06674824 COMPLETED
Monitoring Intercostal Muscles After Extubation
NCT02853201 COMPLETED
Maximal Inspiratory Pressure at Extubation: Relationship With Mortality
NCT02363231 COMPLETED
Evaluation of Mechanical Power and Ventilator Parameters to Predict Weaning Success in the Intensive Care Unit
NCT07268989 RECRUITING
Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation
NCT05480202 COMPLETED NA
Effect of Thoracic Block Technique on Arterial Blood Gases in Children With Atelectasis on Mechanical Ventilation
NCT05821998 COMPLETED NA