Parasternal Intercostal Muscle ThicknessNCT04779463
Role of Ultrasound Assessment of Parasternal Intercostal Muscle Thickness During Weaning From Mechanical Ventilation
An observational study of Parasternal Intercostal Muscle Thickness and Weaning From Mechanical Ventilation, run by Wesameldin Abelrahman Soltan at 1 site in Egypt.
Trial summary
Assessment of the the parasternal intercostal muscles thickness by the ultrasonography as a weaning predictor of the mechanically ventilated patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parasternal Intercostal Muscle Thickness, Weaning From Mechanical Ventilation
- What is being tested?
- Parasternal intercostal muscles thickness ultrasound indicies
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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%.
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine - Menoufia University
Shibīn al Kawm, Menoufia, 32511
Muhammad A AlGhorayeb, MD, +201000203165, drmsebaey@yahoo.com
About this study
Assessment of the the parasternal intercostal muscles thickness by the ultrasonography as a weaning predictor of the mechanically ventilated patients
Read the detailed description
impact of parasternal muscle thickness on the weaning process of the mechanically ventilated patients in ICU
- Being tested
- Parasternal intercostal muscles thickness ultrasound indicies
- Keywords
- mechanical ventilation, parasternal muscle thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal intercostal muscles thickness ultrasound indiciesDiagnostic test
Also called Diaphragmatic thickness
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Parasternal intercostal muscles thickness ultrasound indicies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the start spontaneous breathing trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Jun 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parasternal Intercostal Muscle ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wesameldin Abelrahman Soltan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wesameldin Abelrahman Soltan, Menoufia University
- Investigators
- Wesameldin A Soltan, M.D., Study director, faculty of medicine, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779463
- Sponsor's protocol ID
- Parasternal Intercostals US
- Status last verified
- Feb 2021
- First submitted
- 27 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound Assessment of Parasternal Intercostal Muscle Thickness During Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04779463
- Acronym / sponsor ID
- Parasternal Intercostals US
- Keywords
- mechanical ventilation, parasternal muscle thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wesameldin Abelrahman SoltanUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the the parasternal intercostal muscles thickness by the ultrasonography as a weaning predictor of the mechanically ventilated patients
Detailed description
impact of parasternal muscle thickness on the weaning process of the mechanically ventilated patients in ICU
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical Ventilated patients | – | Diagnostic Test: Parasternal intercostal muscles thickness ultrasound indiciesAll patients are invasively mechanically ventilated at least 24 hours, and are clinically stable as ready to undergo a spontaneous breathing trial. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (14 listed)
- 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.
- Alert.
- Afebrile.
- Adequate cough with absence of excessive tracheobronchial secretion.
- Fraction of inspired oxygen (FIO2) of <50%.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasternal intercostal muscles thickness ultrasound indiciesAlso: Diaphragmatic thicknessParasternal 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. | Diagnostic test | Mechanical Ventilated patients |
Primary outcome
the thickness fraction of the parasternal intercostal muscle as a predictor of successful spontaneous breathing trials
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Parasternal Intercostal Muscle Thickness
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Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients
Postoperative Respiratory Failure, Extubation Failure
Not yet recruitingObservational study
Prediction of Weaning Outcome From Mechanical Ventilation Using Ultrasound
Assess the Prediction of Successful SBT and Extubation of Trachea by Bedside Lung Ultrasound in Mechanically Ventilated Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesameldin A Soltan, M.D. study director
faculty of medicine, Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parasternal Intercostal Muscle Thickness and Weaning From Mechanical Ventilation, run by Wesameldin Abelrahman Soltan at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wesameldin A Soltan, M.D. (0020101012215, wesamsultan1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the thickness fraction of the parasternal intercostal muscle as a predictor of successful spontaneous breathing trials (time frame: Before the start spontaneous breathing trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.