Comparing non-invasive ventilation methods for heart surgery patients
Effects of Non-invasive Ventilation With Different Modalities in Patients Undergoing Heart Surgery: a Randomized Controlled Clinical Trial
This study is testing whether using CPAP or BIPAP helps heart surgery patients recover better than just standard care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidade Federal do Rio Grande do Norte Academic / other |
| Locations | 1 site (Campina Grande, PB) |
| Trial ID | NCT05966337 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of different non-invasive ventilation modalities, specifically CPAP and BIPAP, in patients undergoing cardiac surgery. It is a randomized controlled trial where participants will be assigned to one of three groups: CPAP with usual care, BIPAP with usual care, or usual care alone. The study will take place at Hospital João XXIII in Brazil, and participants will be monitored postoperatively to assess the impact of these ventilation methods on recovery. The trial follows strict ethical guidelines and requires informed consent from all participants.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are stable hemodynamically and undergoing cardiac surgery.
Not a fit: Patients with uncontrolled cardiac arrhythmias or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postoperative recovery and respiratory outcomes for heart surgery patients.
How similar studies have performed: Previous studies have shown promising results with non-invasive ventilation in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients undergoing cardiac surgery * aged over 18 years * stable from the hemodynamic point of view (controlled blood pressure, normocardic * conscious and oriented and cooperative4 * without medical restrictions for carrying out the treatment Exclusion Criteria: * Presence of uncontrolled cardiac arrhythmias (Examples: total atrioventricular block, type 2 2nd degree atrioventricular block, atrial fibrillation, sustained ventricular tachycardia) * previous neuromuscular disease * labyrinthitis and some orthopedic/skeletal muscle restriction. * Unstable angina, stage 3 SAH (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at rest), HR \> 120 bpm at rest, systemic arterial hypotension with clinical repercussions (SBP ≤ 90 mmHg and/or DBP ≤ 60 mmHg),(), * aortic dissection.
Where this trial is running
Campina Grande, PB
- Hospital João XXIII — Campina Grande, Pb, Brazil (Recruiting)
Study contacts
- Study coordinator: Eder R Araújo, doctoral
- Email: eder.rodrigues.araujo@gmail.com
- Phone: +5583988998813
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.