High-Flow Nasal Cannula for Post-Cardiac Surgery Patients

Overseen By Gail Mayo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Does not meet inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 14 days

3192 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

Research Team

Robert E Freundlich, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Exclusion Criteria

Does not meet inclusion criteria

Timeline

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

Treatment Details

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.

Participant Groups

Group I: High Flow Nasal Canula Oxygen Therapy Experimental Treatment 1 Intervention

Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates.

Group II: Provider Choice Standard Care Active Control 1 Intervention

Participants be assigned standard provider choice of standard care therapy physician order set.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula vs Conventional Oxygen Therapy for Postcardiothoracic Surgery. Wang, Y., Huang, D., Ni, Y., et al.[2021]

In a study of 106 patients treated with high flow nasal cannulas (HFNC) in a general hospital setting, significant improvements in oxygen levels were observed, with PaO2 increasing from 68.2 mm Hg to 83.1 mm Hg and O2 saturation rising from 93.1% to 95.1%.

Despite the benefits of HFNC therapy, 30% of patients required further respiratory support, such as noninvasive ventilation or intubation, highlighting the need for careful monitoring of patients' respiratory status while using HFNC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Flow Nasal Cannulas for Oxygenation: An Audit of Its Use in a Tertiary Care Hospital. Sotello, D., Orellana-Barrios, M., Rivas, AM., et al.[2015]

Early use of humidified high-flow nasal cannula (HFNC) therapy in ICU patients is associated with shorter lengths of stay in both the ICU and post-ICU periods, suggesting it may improve patient outcomes.

Delaying the initiation of HFNC therapy is linked to a higher risk of developing ventilator-associated pneumonia and unplanned ICU admissions, indicating that timely intervention is crucial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula in a Mixed Adult ICU. Gaunt, KA., Spilman, SK., Halub, ME., et al.[2023]

A systematic review of 3 randomized controlled trials involving 526 obese patients undergoing cardiac surgery found that high-flow nasal cannula (HFNC) did not significantly improve outcomes like atelectasis score, dyspnea score, reintubation rates, or ICU length of stay compared to conventional oxygen therapy (COT).

Despite the lack of significant differences in these outcomes, HFNC was able to maintain oxygenation in patients, suggesting it may still have a role in postoperative care for this population, though further studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of High-flow Nasal Cannula (HFNC) and Conventional Oxygen Therapy in Obese Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis. Wang, Y., Zhu, J., Wang, X., et al.[2021]

High-flow nasal cannulae (HFNC) may reduce the need for escalation to alternative oxygen therapies compared to standard oxygen therapy, indicating its potential effectiveness in preventing treatment failure in adults with acute respiratory failure (low-certainty evidence from 15 studies with 3044 participants).

HFNC shows similar treatment failure rates and in-hospital mortality compared to non-invasive ventilation (NIV) or non-invasive positive pressure ventilation (NIPPV), suggesting it may not provide additional benefits over these methods (low-certainty evidence from 5 studies with 1758 participants).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-flow nasal cannulae for respiratory support in adult intensive care patients. Lewis, SR., Baker, PE., Parker, R., et al.[2023]

In a meta-analysis of 495 adult postextubation cardiac surgical patients, high-flow nasal cannula (HFNC) therapy significantly reduced the need for escalation of respiratory support compared to conventional oxygen therapy (COT), indicating its efficacy in this patient population.

HFNC was found to be safe, with no severe complications reported and no significant differences in reintubation rates or length of intensive care unit stay between HFNC and COT groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula oxygen therapy vs conventional oxygen therapy in cardiac surgical patients: A meta-analysis. Zhu, Y., Yin, H., Zhang, R., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Use of High-Flow Nasal Cannula Oxygen Outside the ICU. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula vs Conventional Oxygen Therapy for Postcardiothoracic Surgery. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

High Flow Nasal Cannulas for Oxygenation: An Audit of Its Use in a Tertiary Care Hospital. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula in a Mixed Adult ICU. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

Comparison of High-flow Nasal Cannula (HFNC) and Conventional Oxygen Therapy in Obese Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

High-flow nasal cannulae for respiratory support in adult intensive care patients. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula oxygen therapy vs conventional oxygen therapy in cardiac surgical patients: A meta-analysis. [2018]