Mechanical Ventilation vs. Manual Ventilation for Cardiac Patient Transport

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must not be taking: Inhaled vasodilators

Disqualifiers: Mechanical support, Severe RV dysfunction, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Approximately 30 minutes

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a machine or a manual bag better assists cardiac patients with breathing during transport to the ICU after surgery. It compares two oxygen delivery methods: a manual AMBU bag and a mechanical ventilator (Transport Ventilator Mechanical Ventilation). Patients who recently underwent heart surgery and require breathing support in the ICU may qualify. The goal is to identify the safest and most effective method for supporting breathing during transport. As an unphased trial, this study allows patients to contribute to important research that could enhance post-surgery care for future cardiac patients.

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 prior data suggests that mechanical ventilation is safe for cardiac patient transport?

Research has shown that the HAMILTON-C1 ventilator is safe for patients after heart surgery. In a previous study, this ventilator worked well and safely for these patients. Another study found that both manual and machine-based breathing support safely assist in moving patients within a hospital, keeping them stable during transport. Overall, the HAMILTON-C1 ventilator maintains a strong safety record in hospitals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two methods of ventilation during the transport of cardiac patients to the ICU. Unlike manual ventilation using an AMBU bag, which relies on human operation and can be inconsistent, the Hamilton C1 ventilator provides mechanical ventilation that promises more precise and steady airflow. This could lead to better patient outcomes by reducing the risk of human error and ensuring consistent oxygen delivery during critical transport phases.

What evidence suggests that mechanical ventilation is effective for cardiac patient transport?

This trial will compare two ventilation methods during transport to the ICU for cardiac patients. Participants in one arm will receive manual ventilation using an AMBU bag, while those in the other arm will use the Hamilton C1 ventilator. Studies have shown that mechanical ventilators, like the Hamilton C1, effectively assist patients in breathing during transport. These machines maintain steady oxygen and breathing levels, which is crucial for heart patients. Research indicates that using a portable ventilator during hospital transport can reduce risks associated with manual methods, such as uneven breathing support. Portable ventilators are small yet powerful and can adjust to different patient needs. In contrast, manual methods, like using an AMBU bag, might not deliver oxygen as consistently. Overall, mechanical ventilators provide more reliable support during transport for critical heart patients. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need mechanical ventilation after cardiac surgery and are heading to the ICU. It's not for those extubated in the OR, with severe right ventricular dysfunction seen on echocardiography before surgery, or if they refuse to participate. Also excluded are patients needing mechanical circulatory support or therapy with certain inhaled drugs for blood vessel dilation.

Inclusion Criteria

I am over 18 years old.

I am scheduled for heart surgery.

I will need help with breathing and intensive care after surgery.

Exclusion Criteria

On mechanical circulatory support

I have chosen not to participate in certain treatments.

I was removed from a breathing machine right after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are transported to the ICU using either AMBU bag manual ventilation or Hamilton C1 ventilator to compare oxygenation, ventilation, and hemodynamics

Approximately 30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in left and right ventricular function, PaCO2, and P/F ratio before and after transport

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transport Ventilator Mechanical Ventilation

Trial Overview The study compares two ways of helping patients breathe during transport to the ICU: using a manual AMBU bag versus a Hamilton C1 ventilator machine. The goal is to see which method better supports oxygenation and breathing in post-cardiac surgery patients.

How Is the Trial Designed?

Group I: Arm 2: Hamilton C1 ventilator during transport to the ICU Experimental Treatment 1 Intervention

Group II: Arm 1: AMBU bag manual ventilation during transport to the ICU Active Control 1 Intervention

Transport Ventilator Mechanical Ventilation is already approved in United States, European Union for the following indications:

Approved in United States as Transport Ventilator for:

• Emergency ventilation
• Transport of critically ill patients
• Cardiac patient transport

Approved in European Union as Portable Ventilator for:

• Emergency ventilation
• Transport of critically ill patients
• Cardiac patient transport
• Respiratory distress

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

Transporting mechanically ventilated patients carries risks that need careful assessment, but the benefits can outweigh these risks in certain situations.

The use of transport ventilators is debated, as they may not always replicate ICU ventilator functions effectively, raising concerns about complications like hyperventilation or hypoventilation during manual ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should a Portable Ventilator Be Used in All In-Hospital Transports? Holets, SR., Davies, JD.[2022]

In a study of 28 critically ill patients, using a transport ventilator during transport maintained stable blood gas levels, while manual ventilation led to significant respiratory alkalosis, indicating better control with the ventilator.

No patients experienced hemodynamic instability during transport, but two patients using manual ventilation developed cardiac arrhythmias, highlighting the safety advantages of using a transport ventilator.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of blood gases during transport using two methods of ventilatory support. Hurst, JM., Davis, K., Branson, RD., et al.[2019]

In a study involving 16 critically ill patients, the new transport ventilator provided more stable respiratory support during intrahospital transport compared to manual ventilation, with fewer instances of significant deterioration in oxygen levels.

Patients receiving manual ventilation experienced higher respiratory rates and greater variability in tidal volume and pressure compared to those using the transport ventilator, indicating that the ventilator is a safer and more effective option for maintaining respiratory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrahospital transport of critically ill patients using ventilator with patient-triggering function. Nakamura, T., Fujino, Y., Uchiyama, A., et al.[2019]

The Elisée 250 transport ventilator demonstrated a significantly higher task success rate (85.6%) compared to the Oxylog 3000 (66.6%), indicating it is more user-friendly for emergency physicians.

Physicians rated their satisfaction with the Elisée 250 at 81%, significantly higher than the 66% satisfaction score for the Oxylog 3000, suggesting that the Elisée 250 may improve the quality of care during patient transport.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the ventilator-user interface of 2 new advanced compact transport ventilators. Templier, F., Miroux, P., Dolveck, F., et al.[2015]

Transporting critically ill patients within hospitals requires careful monitoring, particularly of expiratory volumes, to ensure their safety during the process.

Using portable mechanical ventilators for transporting ventilator-dependent patients is more effective than manual ventilation, as it reduces the risk of hemodynamic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intrahospital transportation in large hospitals]. Roth, F.[2015]

Transport ventilators must be chosen based on specific patient needs, crew experience, and aircraft type, as no single ventilator fits all scenarios.

Considering environmental and operational factors, along with cost, is crucial for selecting a transport ventilator that effectively supports patient care during air medical transport.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical ventilation during air medical transport: techniques and devices. Rouse, MJ., Branson, R., Semonin-Holleran, R.[2019]

Out of 15 tested transport ventilators, only 2 met all operational targets in both bench and animal models, indicating that not all ventilators are equally effective for patient transport.

Many ventilators showed inaccuracies in delivering set ventilation parameters, with some differing by more than 10% from monitored values, which raises concerns about their reliability in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance comparison of 15 transport ventilators. Chipman, DW., Caramez, MP., Miyoshi, E., et al.[2019]

Citations

1. hamilton-medical.com hamilton-medical.com/en_US/Products/HAMILTON-C1.html

HAMILTON-C1 - Small and powerful ICU mechanical ... A versatile and feature-rich ventilator in a compact size. For all patient groups. It adapts effortlessly to a variety of different settings.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06006208

NCT06006208 | AMBU Bag Manual Ventilation Vs. ... This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2018/11300/effectiveness_of_intrahospital_transportation_of.99.aspx

Effectiveness of intrahospital transportation of... : Medicine Other factors such as the use of portable mechanical ventilator, required transport time, and type of transport have been suggested risk factors relating to ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06006208/ambu-bag-manual-ventilation-vs-transport-ventilator-mechanical-ventilation-for-transport

AMBU Bag Manual Ventilation Vs. Transport ... This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10145333/

Laboratory and clinical evaluation of the MAX transport ... The MAX is a reliable transport ventilator, capable of maintaining adequate ventilation and oxygenation in a majority of mechanically ventilated patients.

6. hamilton-medical.com hamilton-medical.com/dam/jcr:e8fbf16e-0e4b-47b1-a093-d896a1fbb14a/HAMILTON-C1-ops-manual-SW2.1x-en-624326.03.pdf

HAMILTON-C1 - Operator's Manual Familiarize yourself with this operator's manual before using the ventilator on a patient. • Do not simultaneously touch conductive components ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9808113/

Safety of intrahospital transport for MR or CT scans in ... Conclusions. We consider both manual ventilation and mechanical ventilation for intrahospital transport safe for pediatric intensive care patients with CHD.