Mechanical VentilationNCT07083128
Temporal Change in Parasternal Thickening Fraction as a Predictor for Weaning
An observational study of Mechanical Ventilation and Weaning From Mechanical Ventilation, run by Cairo University at 1 site in Egypt.
Trial summary
optimal time to liberate from mechanical ventilation is highly prioritized since improper extubation time lead to serious consequences Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation, Weaning From Mechanical Ventilation, Weaning Failure
- What is being tested?
- Parasternal intercostal thickening
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2025to 20 Mar 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient who are mechanically ventilated for 24 hours or more and ready for weaning
Who may be able to join
- Mechanically ventilated for 24 hours or more ready for weaning
Who cannot join
- Refusal Tracheostomized Inability to obtain ultrasound views patients with neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Changes in Parasternal Intercostal Muscle Thickening as a Possible Biomarker for Successful Weaning From Mechanical Ventilation: a Prospective Observational Study
optimal time to liberate from mechanical ventilation is highly prioritized since improper extubation time lead to serious consequences
Read the detailed description
Several parameters were proposed to assess proper weaning time including diaphragmatic ultrasound and extra-diaghragmatic muscles. previous research concluded an ability of parasternal intercostal (PIC) thickening to predict weaning outcomes. researchers of current study assumed that temporal changes in PIC thickening would provide greater ability to predict weaning outcomes
- Being tested
- Parasternal intercostal thickening
- Keywords
- Parasternal thickening; failed weaning; extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal intercostal thickeningDevice
Temporal change in parasternal intercostal thickening fraction at initiation and 30 minutes of spontaneous breathing trial
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of change in PIC-TF in predicting successful weaning from mechanical ventilation
percentage of change in PIC TF in predicting weaning outcome (PIC TF30-PIC TF0)
Measured: At baseline and 30 minutes after initiation of spontaneous breathing trial
Secondary outcomes (1)
Accuracy of change in PIC-TF to predict reintubation
percentage of change in PIC TF at start and end of spontaneous breathing trial (PIC TF30-PIC TF0)
Measured: At baseline and 30 minutes after initiation of 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 posted24 Jul 2025
- Study start13 Jul 2025
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083128
- Sponsor's protocol ID
- Temporal change in PIC
- Status last verified
- Mar 2026
- First submitted
- 5 Jul 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shared due to confidentiality, legal constraints, or the need to protect intellectual property rights.
Publications
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.
PubMed 39174907Helmy 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.
PubMed 36961635Helmy 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.
PubMed 35487407Helmy MA, Magdy Milad L, Osman SH, Ali MA, Hasanin A. Diaphragmatic excursion: A possible key player for predicting successful weaning in patients with severe COVID-19. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100875. doi: 10.1016/j.accpm.2021.100875. Epub 2021 Apr 30. No abstract available.
PubMed 33940248Adolf Helmy M, Magdy Milad L, Hasanin A, Mostafa M. The novel use of diaphragmatic excursion on hospital admission to predict the need for ventilatory support in patients with coronavirus disease 2019. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100976. doi: 10.1016/j.accpm.2021.100976. Epub 2021 Nov 5.
PubMed 34748940
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Changes in Parasternal Intercostal Muscle Thickening as a Possible Biomarker for Successful Weaning From Mechanical Ventilation: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07083128
- Acronym / sponsor ID
- Temporal change in PIC
- Keywords
- Parasternal thickening; failed weaning; extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 24 Jul 2025 (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.
optimal time to liberate from mechanical ventilation is highly prioritized since improper extubation time lead to serious consequences
Detailed description
Several parameters were proposed to assess proper weaning time including diaphragmatic ultrasound and extra-diaghragmatic muscles. previous research concluded an ability of parasternal intercostal (PIC) thickening to predict weaning outcomes. researchers of current study assumed that temporal changes in PIC thickening would provide greater ability to predict weaning outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient who are mechanically ventilated for 24 hours or more and ready for weaning
Key inclusion criteria (1 listed)
- Mechanically ventilated for 24 hours or more ready for weaning
Key exclusion criteria (1 listed)
- Refusal Tracheostomized Inability to obtain ultrasound views patients with neuromuscular disease
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 thickeningTemporal change in parasternal intercostal thickening fraction at initiation and 30 minutes of spontaneous breathing trial | Device | – |
Primary outcome
Accuracy of change in PIC-TF in predicting successful weaning from mechanical ventilation
Time frame: At baseline and 30 minutes after initiation of spontaneous breathing trial
percentage of change in PIC TF in predicting weaning outcome (PIC TF30-PIC TF0)
1 secondary outcome
Accuracy of change in PIC-TF to predict reintubation
Time frame: At baseline and 30 minutes after initiation of spontaneous breathing trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Results publication: PubMed 39174907Helmy 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.
- Results publication: PubMed 36961635Helmy 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.
- Results publication: PubMed 35487407Helmy 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.
- Results publication: PubMed 33940248Helmy MA, Magdy Milad L, Osman SH, Ali MA, Hasanin A. Diaphragmatic excursion: A possible key player for predicting successful weaning in patients with severe COVID-19. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100875. doi: 10.1016/j.accpm.2021.100875. Epub 2021 Apr 30. No abstract available.
- Results publication: PubMed 34748940Adolf Helmy M, Magdy Milad L, Hasanin A, Mostafa M. The novel use of diaphragmatic excursion on hospital admission to predict the need for ventilatory support in patients with coronavirus disease 2019. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100976. doi: 10.1016/j.accpm.2021.100976. Epub 2021 Nov 5.
- Individual participant dataSharing planned: Undecided. IPD may not be shared due to confidentiality, legal constraints, or the need to protect intellectual property rights.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mechanical Ventilation and Weaning From Mechanical Ventilation, run by Cairo University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of change in PIC-TF in predicting successful weaning from mechanical ventilation (time frame: At baseline and 30 minutes after initiation of spontaneous breathing trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083128, which also lists 5 linked publications.
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 25 Mar 2026.