Evaluating lung pressure changes with abdominal weight in ventilated patients
Lung Overdistension and Abdominal Pressure Rise: an EIT Based Pilot Study
NA · University of Padova · NCT06174636
This study is testing how adding weight to the abdomen affects breathing and lung function in patients on a ventilator who have trouble breathing.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Padova (other) |
| Locations | 1 site (Padova) |
| Trial ID | NCT06174636 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study aims to assess the effects of applying abdominal weight on airway pressure, esophageal pressure, and lung volume distribution in mechanically ventilated patients suffering from respiratory failure. The study will utilize electrical impedance tomography (EIT) to monitor these changes after increasing intra-abdominal pressure. The goal is to better understand how abdominal pressure influences respiratory mechanics in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients on invasive mechanical ventilation due to acute respiratory failure with specific criteria for PEEP trials.
Not a fit: Patients with severe obesity, significant hemodynamic instability, or contraindications to the interventions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with respiratory failure, enhancing their ventilation and overall outcomes.
How similar studies have performed: While this approach is innovative, similar studies exploring the effects of abdominal pressure on respiratory mechanics have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 \<300 mmHg) * Need of PEEP trial * Need of urinary catheter (used to measure IAP) Exclusion Criteria: * Contraindication to EIT use * Pacemaker or other metal device in thoracic region * Contraindication to abdominal weight placement * Surgical or traumatic incision on the abdomen * Severe abdominal hypertension * Esophageal diseases that counterindicate naso-gastric tube placement * Severe hemodynamic instability (norepinephrine \> 0.1 mcg/kg/min; dobutamine or dopamine \> 5 mcg/kg/min; epinephrine every dosage) * Severe obesity (BMI \> 35 kg/m2) * Need of \> 7 kg weight to reach 5 mmHg IAP increase
Where this trial is running
Padova
- Azienda Ospedaliera Università di Padova — Padova, Italy (RECRUITING)
Study contacts
- Study coordinator: Paolo Persona, MD, PhD
- Email: ppersona75@gmail.com
- Phone: +39 3389745902
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.
Conditions: Respiratory Failure, Respiratory Distress Syndrome, Adult, Abdominal pressure, Overdistension