Mechanical Ventilation ComplicationNCT05495763
The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates
An observational study of Mechanical Ventilation Complication, run by Noha Saied Ibrahim at 1 site in Egypt.
Trial summary
Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the thorax , and determining the thickness of them would be a useful parameter in evaluating… Read more about this study
- Who is it for?
- Ages 5 minutes to 28 days
- Conditions the study is for
- Mechanical Ventilation Complication
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2022to Jan 2023
- 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 5 minutes to 28 days
- All sexes
- Child
Study population: The study will be conducted on neonates admitted to NICU.
Who may be able to join
- Preterm infants from 28-36 weeks gestation
- In need for invasive mechanical ventilation according to work of breathing, oxygen saturation and blood gases .
Who cannot join
- 1) Significant congenital anomalies including cardiac, abdominal or respiratory.
- 2) Congenital anomalies involving the diaphragm. 3) Phrenic nerve paralysis. 4) Congenital muscular dystrophies. 5) Major upper or lower airway anomalies. 6) Storage diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Aya M Shebana, MD, 01222273323
About this study
Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the thorax , and determining the thickness of them would be a useful parameter in evaluating respiratory muscle activity.
This study will add the impact of mechanical ventilation on the diaphragm and intercostal muscles in preterm infants using ultrasound.
- Conditions
- Mechanical Ventilation Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of mechanical ventilation on diaphragm and intercostal muscles using ultrasound
Using Ultrasound to measure Intercostal Muscles thickness and diaphragmatic thickness and excursion for assessing the impact of the mechanical ventilation on muscle power predicting weaning from ventilation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noha Saied Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Saied Ibrahim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495763
- Sponsor's protocol ID
- Noha ibrahim
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates
- ClinicalTrials.gov ID
- NCT05495763
- Acronym / sponsor ID
- Noha ibrahim
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Noha Saied IbrahimUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 10 Aug 2022 (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.
Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the thorax , and determining the thickness of them would be a useful parameter in evaluating respiratory muscle activity.
This study will add the impact of mechanical ventilation on the diaphragm and intercostal muscles in preterm infants using ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 minutes to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- The study will be conducted on neonates admitted to NICU.
Key inclusion criteria (2 listed)
- Preterm infants from 28-36 weeks gestation
- In need for invasive mechanical ventilation according to work of breathing, oxygen saturation and blood gases .
Key exclusion criteria (2 listed)
- 1) Significant congenital anomalies including cardiac, abdominal or respiratory.
- 2) Congenital anomalies involving the diaphragm. 3) Phrenic nerve paralysis. 4) Congenital muscular dystrophies. 5) Major upper or lower airway anomalies. 6) Storage diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The impact of mechanical ventilation on diaphragm and intercostal muscles using ultrasound
Time frame: 6 months
Using Ultrasound to measure Intercostal Muscles thickness and diaphragmatic thickness and excursion for assessing the impact of the mechanical ventilation on muscle power predicting weaning from ventilation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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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.
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 Complication, run by Noha Saied Ibrahim 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 2 inclusion and 2 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 16 Aug 2022. 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 Noha Ibrahim, MB, BCh (01064099564, Nohasaied2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of mechanical ventilation on diaphragm and intercostal muscles using ultrasound (time frame: 6 months). 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 16 Aug 2022.