Role of Ultrasound Assessment of Parasternal Intercostal Muscle Thickness During Weaning From Mechanical Ventilation
1 other identifier
observational
40
1 country
1
Brief Summary
Assessment of the the parasternal intercostal muscles thickness by the ultrasonography as a weaning predictor of the mechanically ventilated patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedMarch 3, 2021
February 1, 2021
9 months
February 27, 2021
February 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
All patients are invasively mechanically ventilated at least 24 hours, and are clinically stable as ready to undergo a spontaneous breathing trial (SBT).
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine - Menoufia University
Shibīn al Kawm, Menoufia, 32511, Egypt
Study Officials
- STUDY DIRECTOR
Wesameldin A Soltan, M.D.
faculty of medicine, Menoufia University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 27, 2021
First Posted
March 3, 2021
Study Start
June 1, 2020
Primary Completion
March 1, 2021
Study Completion
April 1, 2021
Last Updated
March 3, 2021
Record last verified: 2021-02