Reducing reintubation risk in high-risk cardiac surgery patients using high-flow nasal cannula
Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula
This study is testing if using high-flow nasal cannula oxygen can help high-risk heart surgery patients avoid needing to be reintubated after their surgery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04782817 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the rates of reintubation and outcomes between patients treated with high-flow nasal cannula (HFNC) oxygen therapy and those receiving standard care following cardiac surgery. HFNC may help facilitate early extubation and prevent reintubation in high-risk patients in the cardiovascular intensive care unit. The study will be conducted as a pilot trial in a single high-volume center, where patients will be randomized to receive either HFNC or standard care upon being deemed ready for extubation. Data on reintubation and patient outcomes will be collected until discharge.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who have undergone cardiac surgery and are intubated upon arrival at the cardiovascular intensive care unit.
Not a fit: Patients who do not meet the inclusion criteria, such as those who have not undergone cardiac surgery or are not intubated, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of reintubation in high-risk cardiac surgery patients, improving their recovery outcomes.
How similar studies have performed: While there is limited high-quality clinical data on the use of HFNC in this specific population, similar approaches in other settings have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 and over treated in the Vanderbilt Cardiovascular Intensive Care Unit following cardiac surgery (defined as surgery on the heart or thoracic aorta, excluding percutaneous procedures) * Surgical duration (anesthesia start to anesthesia stop) of at least 3 hours. * Intubated at the time of arrival in the Cardiovascular Intensive Care Unit * Extubated to occur at some point following arrival in the Cardiovascular Intensive Care Unit with an order to extubate the patient by a treating provider. Exclusion Criteria: * Does not meet inclusion criteria
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Robert E Freundlich, MD — Vanderbilt University Medical Center
- Study coordinator: Robert E Freundlich, MD
- Email: robert.e.freundlich@vumc.org
- Phone: (615)936-6608
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.