Understanding diaphragm pressure and contraction in patients with respiratory issues
A Study on the Relationship Between the Trans-diaphragmatic Pressure and the Contraction of the Diaphragm
This study is testing how well the diaphragm works in patients with breathing problems to see if it can help them safely come off mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Thessaly Academic / other |
| Locations | 1 site (Larissa, Thessaly) |
| Trial ID | NCT03802383 on ClinicalTrials.gov |
What this trial studies
This observational study aims to clarify the relationship between trans-diaphragmatic pressure and diaphragmatic contraction parameters using ultrasound. Patients will undergo a Spontaneous Breathing Trial (S.B.T.) where various measurements, including diaphragm thickness and pressure metrics, will be taken. The study will assess the effectiveness of weaning patients off mechanical ventilation by monitoring their respiratory function and diaphragm performance. The findings could help improve strategies for managing patients with respiratory failure.
Who should consider this trial
Good fit: Ideal candidates include patients with respiratory failure who meet specific respiratory and cardiovascular criteria and are able to initiate ventilatory effort.
Not a fit: Patients who are obese, under 18 years old, pregnant, or have significant reversible comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of diaphragm function and improve weaning protocols for patients on mechanical ventilation.
How similar studies have performed: While the approach of using diaphragm metrics in weaning has been explored, this specific relationship between trans-diaphragmatic pressure and contraction parameters is less commonly studied, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients meeting the following standards. * Respiratory Criteria * PaO2≥ 60mmHg with Fraction of Inspired Oxygen (FiO2) ≤ 40-50% \& Positive End Expiratory Pressure (PEEP) ≤ 5-8 cm H2O * PaCO2 normal or at the level of reference (allowed hypercapnia is allowed) * Patient is able to start ventilatory effort * Cardiovascular Criteria * Absence of myocardial ischemia * Heart Rate ≤140 bpm * Arterial Pressure normal without vasoconstriction or with minimum vasoconstriction support * Adequate level of consciousness o Glasgow Coma Scale (GCS ≥ 13) * Absence of other reversible comorbidities * Afebrile Patient * Without important electrolyte disorders Exclusion Criteria: * Obese patients with B.M.I. \>35 * pregnant women * patients \<18 years old
Where this trial is running
Larissa, Thessaly
- Critical Care Unit — Larissa, Thessaly, Greece (Recruiting)
Study contacts
- Study coordinator: Demosthenes Makris
- Email: appollon7@hotmail.com
- Phone: +306943706079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.