81 Participants Needed

Mechanical Ventilation vs. Manual Ventilation for Cardiac Patient Transport

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Thomas Jefferson University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.

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 Transport Ventilator Mechanical Ventilation, Portable Ventilator, Automatic Transport Ventilator for cardiac patient transport?

Research shows that using a transport ventilator during patient transport provides more consistent breathing support compared to manual ventilation, helping to maintain stable blood gas levels and reducing the risk of complications like respiratory alkalosis (a condition where the blood becomes too alkaline).12345

Is using a transport ventilator safe for patients during transport?

Transport ventilators are generally safe for patients during transport, as they provide reliable control of breathing without causing significant changes in blood gases or hemodynamic instability. Manual ventilation, on the other hand, can lead to issues like respiratory alkalosis and cardiac arrhythmias in some patients.12346

How does the treatment 'Transport Ventilator Mechanical Ventilation' differ from other treatments for cardiac patient transport?

Transport ventilators provide consistent and controlled ventilation during patient transport, unlike manual ventilation which can lead to issues like respiratory alkalosis (an imbalance in blood pH) and cardiac arrhythmias. This makes transport ventilators a more reliable option for maintaining stable respiratory conditions.12347

Eligibility Criteria

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.
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Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Hamilton C1 ventilator during transport to the ICUExperimental Treatment1 Intervention
Group II: Arm 1: AMBU bag manual ventilation during transport to the ICUActive Control1 Intervention

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Transport Ventilator for:
  • Emergency ventilation
  • Transport of critically ill patients
  • Cardiac patient transport
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Portable Ventilator for:
  • Emergency ventilation
  • Transport of critically ill patients
  • Cardiac patient transport
  • Respiratory distress

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+

Findings from Research

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.
Comparison of blood gases during transport using two methods of ventilatory support.Hurst, JM., Davis, K., Branson, RD., et al.[2019]
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.
Should a Portable Ventilator Be Used in All In-Hospital Transports?Holets, SR., Davies, JD.[2022]
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.
Intrahospital transport of critically ill patients using ventilator with patient-triggering function.Nakamura, T., Fujino, Y., Uchiyama, A., et al.[2019]

References

Comparison of blood gases during transport using two methods of ventilatory support. [2019]
Should a Portable Ventilator Be Used in All In-Hospital Transports? [2022]
Intrahospital transport of critically ill patients using ventilator with patient-triggering function. [2019]
Evaluation of the ventilator-user interface of 2 new advanced compact transport ventilators. [2015]
[Intrahospital transportation in large hospitals]. [2015]
Mechanical ventilation during air medical transport: techniques and devices. [2019]
Performance comparison of 15 transport ventilators. [2019]