3192 Participants Needed

High-Flow Nasal Cannula for Post-Cardiac Surgery Patients

RE
GM
Overseen ByGail Mayo
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare reintubation rates and outcomes of patients treated with high-flow nasal canula oxygen therapy (HFNC) and patients treated with provider choice of standard care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How is high-flow nasal cannula treatment different from other treatments for post-cardiac surgery patients?

High-flow nasal cannula (HFNC) treatment is unique because it delivers a high flow of humidified air and oxygen through a nasal tube, which can be more comfortable and effective than conventional oxygen therapy, especially for patients who have just had cardiac surgery.12345

What data supports the effectiveness of the treatment High-Flow Nasal Cannula for Post-Cardiac Surgery Patients?

Research shows that high-flow nasal cannula (HFNC) oxygen therapy is widely used and effective in patients after cardiothoracic surgery, providing better oxygen delivery compared to conventional methods. It is also used safely in various hospital settings, including outside intensive care units, indicating its versatility and potential benefits for post-surgery patients.24678

Who Is on the Research Team?

RE

Robert E Freundlich, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had heart or thoracic aorta surgery lasting at least 3 hours and are in the Vanderbilt Cardiovascular Intensive Care Unit. They must be intubated upon ICU arrival with plans to remove the breathing tube later.

Inclusion Criteria

Intubated at the time of arrival in the Cardiovascular Intensive Care Unit
My surgery lasted at least 3 hours from start to finish.
I am planned to be taken off a ventilator after arriving in the ICU.
See 1 more

Exclusion Criteria

Does not meet inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either high-flow nasal cannula oxygen therapy or provider choice of standard care post-extubation

Up to 14 days
Continuous monitoring in the cardiovascular intensive care unit

Follow-up

Participants are monitored for reintubation and other outcomes until hospital discharge

Up to 14 days

What Are the Treatments Tested in This Trial?

Interventions

  • Provider choice standard care order set
  • Recommendation for high flow nasal cannula oxygen therapy order set
Trial Overview The study compares two post-surgery treatments: high-flow nasal cannula oxygen therapy (HFNC) versus standard care chosen by the provider, focusing on how they affect the need to reintubate patients after cardiac surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: High Flow Nasal Canula Oxygen TherapyExperimental Treatment1 Intervention
Group II: Provider Choice Standard CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

High-flow nasal cannula (HFNC) therapy significantly improved dyspnea, breathing frequency, and oxygen saturation in 90 out of 111 patients treated outside the ICU, indicating its efficacy in non-ICU settings.
Despite the benefits observed, the study reported a high overall mortality rate of 50%, suggesting that HFNC may often be used in a palliative context, particularly among patients with do not resuscitate (DNR) orders.
The Use of High-Flow Nasal Cannula Oxygen Outside the ICU.Zemach, S., Helviz, Y., Shitrit, M., et al.[2020]
In a study of 157 children under 24 months treated with high-flow nasal cannula (HFNC) for bronchiolitis, 78.3% were successfully weaned off HFNC and discharged home, indicating its efficacy in managing respiratory distress in a pediatric ward setting.
HFNC was safely administered without any serious complications such as aspiration or pneumothorax, and most patients who required transfer to a pediatric intensive care unit (PICU) did not need more invasive respiratory support, suggesting that HFNC can be effectively used in community hospitals.
High-Flow Nasal Cannula Use in Children with Bronchiolitis in a Community Hospital Setting: Evaluation of Safety, Flow Limits, and Intensive Care Unit Transfers.Van Winkle, PJ., Castro, AM., Salvador-Lloyd, SA., et al.[2022]
High-flow nasal cannula (HFNC) oxygen therapy significantly reduces the need for increased respiratory support and lowers the re-intubation rate in adults after cardiothoracic surgery, based on a review of 8 studies with 1,086 participants.
HFNC may also shorten the length of hospital stays, although it does not significantly affect ICU stay, pulmonary complications, or mortality rates.
High-Flow Nasal Cannula vs Conventional Oxygen Therapy for Postcardiothoracic Surgery.Wang, Y., Huang, D., Ni, Y., et al.[2021]

Citations

The Use of High-Flow Nasal Cannula Oxygen Outside the ICU. [2020]
High-Flow Nasal Cannula Use in Children with Bronchiolitis in a Community Hospital Setting: Evaluation of Safety, Flow Limits, and Intensive Care Unit Transfers. [2022]
High-Flow Nasal Cannula vs Conventional Oxygen Therapy for Postcardiothoracic Surgery. [2021]
High Flow Nasal Cannulas for Oxygenation: An Audit of Its Use in a Tertiary Care Hospital. [2015]
High-Flow Nasal Cannula in a Mixed Adult ICU. [2023]
Comparison of High-flow Nasal Cannula (HFNC) and Conventional Oxygen Therapy in Obese Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis. [2021]
High-flow nasal cannulae for respiratory support in adult intensive care patients. [2023]
High-flow nasal cannula oxygen therapy vs conventional oxygen therapy in cardiac surgical patients: A meta-analysis. [2018]
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