Comparing manual and mechanical ventilation for cardiac patients during transport
Ventilation During Intensive Care Unit Transport After Cardiac Surgeries; When Should We Use a Ventilator?
This study is testing whether using a manual bag or a mechanical ventilator is better for helping heart patients breathe during their transport to the ICU after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06006208 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of manual ventilation using an AMBU bag versus mechanical ventilation with a Hamilton transport ventilator for cardiac patients being transported to the ICU after surgery. The study will assess key parameters such as oxygenation, ventilation, hemodynamics, and cardiac function in both groups. By establishing clinical evidence on the best ventilation method during transport, the trial seeks to improve patient outcomes and guide clinical practice. The study involves a two-arm design where patients will be monitored for changes in their respiratory and cardiovascular status.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have undergone cardiac surgery and require postoperative mechanical ventilation.
Not a fit: Patients who may not benefit from this study include those who refuse participation, have been extubated in the operating room, or have severe right ventricular dysfunction.
Why it matters
Potential benefit: If successful, this study could provide evidence-based guidance on the optimal ventilation method for cardiac patients during transport, potentially improving their recovery and outcomes.
How similar studies have performed: While there is limited clinical evidence specifically comparing these two ventilation methods during transport, similar studies in other contexts have shown the importance of ventilation strategies in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years old (any gender or race) * Cardiac surgery * Require postoperative mechanical ventilation and care in the ICU. Exclusion Criteria: * Patients' refusal * Extubation in OR * On mechanical circulatory support * Requirement for postoperative therapy with inhaled pulmonary vasodilators (epoprostenol (FLOLAN), inhaled nitric oxide, etc.) * Severe RV dysfunction with preoperative echocardiography * Contraindication to TEE and pulmonary artery catheter.
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
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.