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High-Flow Nasal Cannula for Post-Cardiac Surgery Patients

N/A

Recruiting

Led By Robert E Freundlich, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgical duration (anesthesia start to anesthesia stop) of at least 3 hours.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Study Summary

This trial will compare the reintubation rates and outcomes of patients treated with high-flow nasal cannula oxygen therapy versus those treated with standard care.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed, HFNC generally can cause dryness of airways, nosebleeds, and discomfort. Standard care side effects depend on the treatment selected by healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My surgery lasted at least 3 hours from start to finish.

Select...

I am an adult who had heart or major blood vessel surgery and was treated in the Vanderbilt Cardiovascular ICU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reintubation within 48 hours of extubation

Secondary outcome measures

Perinatal death

Hospital length of stay

In-hospital mortality

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High Flow Nasal Canula Oxygen TherapyExperimental Treatment1 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 CareActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

669,005 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,848,435 Total Patients Enrolled

Robert E Freundlich, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Provider choice standard care order set (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04782817 — N/A

Intubation Research Study Groups: High Flow Nasal Canula Oxygen Therapy, Provider Choice Standard Care

Intubation Clinical Trial 2023: Provider choice standard care order set Highlights & Side Effects. Trial Name: NCT04782817 — N/A

Provider choice standard care order set (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782817 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of enrollees for this research endeavor?

"Yes, the information on clinicaltrials.gov attests to this research being actively looking for participants. It was published on November 1st 2021 and most recently updated on November 2nd 2022; 3192 subjects are needed at a single medical facility."

Answered by AI

Are applications for this research program currently being accepted?

"Affirmative. Evidenced by clinicaltrials.gov, this medical trial is presently looking for participants. It was first advertised on November 1st 2021 and has been recently updated on November 2nd 2022; the aim being to recruit 3192 individuals from a single clinic."

Answered by AI

Recent research and studies

Journal of Cardiothoracic and Vascular AnesthesiaJournal

Variation in Tracheal Reintubations Among Patients Undergoing Cardiac Surgery Across Washington State Hospitals

Khandelwal, Nita, Christopher R. Dale, David C. Benkeser, Aaron M. Joffe, Norbert David Yanez III, and Miriam M. Treggiari. 2015. “Variation in Tracheal Reintubations Among Patients Undergoing Cardiac Surgery Across Washington State Hospitals”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2014.11.009.

Journal of Cardiothoracic and Vascular AnesthesiaJournal

Immediate Extubation After Off-pump Coronary Artery Bypass Graft Surgery in 1,196 Consecutive Patients: Feasibility, Safety and Predictors of When Not to Attempt It

Dorsa, Alberto G., Adriana I. Rossi, Jorge Thierer, Bernardo Lupiañez, Juan M. Vrancic, Guillermo N. Vaccarino, Fernando Piccinini, et al.. 2011. “Immediate Extubation After Off-pump Coronary Artery Bypass Graft Surgery in 1,196 Consecutive Patients: Feasibility, Safety and Predictors of When Not to Attempt It”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2010.08.013.

Critical CareJournal

Current Evidence for the Effectiveness of Heated and Humidified High Flow Nasal Cannula Supportive Therapy in Adult Patients with Respiratory Failure

Roca, Oriol, for the Spanish Multidisciplinary Group of High Flow Supportive Therapy in Adults (HiSpaFlow), Gonzalo Hernández, Salvador Díaz-Lobato, José M. Carratalá, Rosa M. Gutiérrez, and Joan R. Masclans. 2016. “Current Evidence for the Effectiveness of Heated and Humidified High Flow Nasal Cannula Supportive Therapy in Adult Patients with Respiratory Failure”. Critical Care. Springer Science and Business Media LLC. doi:10.1186/s13054-016-1263-z.

Respiratory CareJournal