Mechanical Ventilation Modes for Preventing Muscle Wasting

Recruiting at 1 trial location

Overseen By John P Kress, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Pregnancy, COPD, Asthma, others

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

Compensation: Varies

Number of Visits: 1

Duration: 28 days

468 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the study is to determine how controlled mode ventilation and support mode ventilation impact ventilator-free days and diaphragmatic atrophy.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Assist Control Mode Mechanical Ventilation and its related modes?

Research suggests that pressure-regulated volume control (PRVC), a mode of mechanical ventilation, can lower peak inspiratory pressure compared to conventional volume control ventilation, which may improve respiratory mechanics in patients with acute respiratory failure. ^{1 2 3 4 5}

Is mechanical ventilation safe for humans?

Mechanical ventilation modes like Pressure Regulated Volume Control (PRVC) and Volume-Controlled Continuous Mandatory Ventilation (VC-CMV) are generally used in intensive care settings and have been studied for safety. While PRVC can lower peak airway pressures, it may sometimes lead to issues like patient-ventilator dyssynchrony (when the machine and patient are not in sync). Overall, these modes are commonly used and considered safe, but they require careful monitoring by healthcare professionals. ^{1 2 3 4 6}

How does Assist Control Mode Mechanical Ventilation differ from other treatments for preventing muscle wasting?

Assist Control Mode Mechanical Ventilation is unique because it provides positive pressure assistance based on the patient's own breathing efforts, which helps prevent muscle wasting by minimizing disuse atrophy of the respiratory muscles. This mode can also facilitate the weaning process and usually requires lower ventilator pressures compared to other modes. ^{1 7 8 9 10}

Research Team

Bhakti Patel, MD

Principal Investigator

University of Chicago

John P Kress, MD

Principal Investigator

University of Chicago

Roger Struble, MD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for adults over 18 who've been on a mechanical ventilator for less than 36 hours. It's not suitable for those with recent cardiac arrest, high spinal injuries, past ventilation within six months, pregnancy, muscle paralysis drugs in use, diaphragm issues or neuromuscular diseases, tracheostomies, expected quick weaning from the ventilator or severe COPD/asthma.

Exclusion Criteria

You are pregnant.

I have a history of muscle disease or diaphragm paralysis.

I have not used muscle relaxants recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 24 hours

1 visit (in-person)

Treatment

Participants are randomized to either volume support mode or assist control mode ventilation, with diaphragm thickness measured daily by ultrasound

28 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including discharge destination and mortality

90 days

Treatment Details

Interventions

• Assist Control Mode Mechanical Ventilation
• Volume Support Mode Mechanical Ventilation

Trial Overview The study aims to compare two types of mechanical ventilation: Assist Control Mode and Volume Support Mode. The focus is on their effects on reducing time spent on a ventilator and preventing weakening of the diaphragm muscle due to prolonged use of these machines.

Participant Groups

Group I: Volume Support Mode Mechanical Ventilation Active Control 1 Intervention

Volume support mode ventilation is a spontaneous mode where a target goal volume is set on the ventilator. This ventilatory strategy is dependent on patients spontaneously breathing and triggering (or activating) the ventilator to support the breath. The ventilator adjusts the amount of pressure support to deliver with each breath (i.e. if the patient's tidal volume is greater than the set target volume, then the ventilator will decrease the amount of pressure support in the subsequent breath to try to achieve the goal volume and vice versa). The respiratory rate is not set in this mode of ventilation and is dependent on the patient. For patients randomized to this mode, the goal tidal volume will be set at 6 cc/kg of ideal body weight (IBW).

Group II: Assist Control Mode Mechanical Ventilation Active Control 1 Intervention

In assist control mode ventilation, the machine is programmed to deliver a set tidal volume and set respiratory rate. Patients can breathe over the set respiratory rate, but the volume of breath that they receive is fixed and delivered by the ventilator. For patients randomized to this mode, the tidal volume will be set at 6 cc/kg of ideal body weight (IBW).

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

In a study involving 44 patients with acute respiratory failure, pressure-regulated volume control (PRVC) ventilation resulted in significantly lower peak inspiratory pressures compared to conventional volume control (VC) ventilation (20 cmH2O vs 24 cmH2O, P < 0.0001).

Despite the lower pressures with PRVC, the study did not find significant improvements in overall patient outcomes, indicating that while PRVC may be safer in terms of pressure management, its efficacy in improving survival or recovery remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of volume control and pressure-regulated volume control ventilation in acute respiratory failure. Guldager, H., Nielsen, SL., Carl, P., et al.[2022]

In a pilot trial involving 137 patients with acute respiratory failure, the use of patient-triggered adaptive pressure control (APC-CMV) was found to be feasible, with 96% of subjects receiving the assigned mode within the first hour of ICU admission.

Patients on APC-CMV spent a higher proportion of the first 24 hours on the assigned mode (95%) compared to those on volume control (VC-CMV) (84%), suggesting that APC-CMV may offer better adherence to the ventilation strategy in the early stages of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pragmatic Pilot Trial Comparing Patient-Triggered Adaptive Pressure Control to Patient-Triggered Volume Control Ventilation in Critically Ill Adults. Gibbs, KW., Forbes, JL., Harrison, KJ., et al.[2023]

Pressure-regulated volume control (PRVC) ventilation is designed to deliver a set tidal volume while minimizing airway pressure, making it a popular choice in intensive care units.

However, in two reported cases, PRVC ventilation led to maladaptive responses, causing patient-ventilator dyssynchrony, which highlights the need for careful monitoring and adjustment of this ventilation mode.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure Regulated Volume Control (PRVC): Set it and forget it? Singh, G., Chien, C., Patel, S.[2020]

In a study involving 14 intubated patients, pressure-support ventilation (PSV) was found to be significantly more comfortable than volume-controlled continuous mandatory ventilation (VC-CMV), with 11 out of 14 patients preferring PSV.

The average comfort score for PSV was 83, compared to 70 for VC-CMV and 62 for baseline ventilation, indicating that PSV may be the better choice for awake intubated patients without compromising physiological parameters like respiratory rate and oxygen saturation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient comfort during pressure support and volume controlled-continuous mandatory ventilation. Betensley, AD., Khalid, I., Crawford, J., et al.[2008]

In a study involving 212 very low-birth-weight infants, pressure-regulated volume control (PRVC) ventilation did not significantly increase the proportion of infants who were alive and extubated at 14 days compared to synchronized intermittent mandatory ventilation (SIMV).

Although PRVC did not improve overall outcomes, it was associated with a lower failure rate (20% vs 33% for SIMV), suggesting it may be a safer option for maintaining ventilation in these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure-regulated volume control ventilation vs synchronized intermittent mandatory ventilation for very low-birth-weight infants: a randomized controlled trial. D'Angio, CT., Chess, PR., Kovacs, SJ., et al.[2007]

Control ventilation is beneficial for patients with severe respiratory issues as it ensures consistent delivery of air, reducing the risk of breathing complications and conserving the patient's energy.

Assist-control ventilation allows patients to initiate their own breaths while still receiving support from the respirator, making it suitable for those who can breathe but need help maintaining adequate ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Control and assist-control modes of mechanical ventilation]. Reina Ferragut, CM.[2019]

Partial patient-controlled mechanical support mode ventilators help patients by providing positive pressure assistance when their breathing effort decreases, which can reduce muscle atrophy and aid in the weaning process from ventilation.

The effectiveness of these ventilators in improving gas exchange and relieving breathlessness relies on how well the ventilator settings match the patient's breathing needs, highlighting the importance of patient-ventilator interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-ventilator interaction during the triggering phase. Racca, F., Squadrone, V., Ranieri, VM.[2005]

In a randomized trial involving 36 infants with a median gestational age of 29 weeks, no significant differences were observed in the work of breathing, respiratory muscle strength, or asynchrony between assist control ventilation (ACV) and pressure support ventilation (PSV) during weaning.

The duration of weaning was similar for both ACV (34 hours) and PSV (27 hours), indicating that both methods are equally effective in this context when similar inflation times are applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised weaning trial comparing assist control to pressure support ventilation. Shefali-Patel, D., Murthy, V., Hannam, S., et al.[2022]

A new SpO2-sensitive adaptive backup ventilation mode significantly reduced the incidence of oxygen desaturations by 33% and their duration by 52% in preterm infants undergoing proportional assist ventilation (PAV).

The study, conducted in a neonatal intensive care unit with 11 preterm infants, demonstrated that this adaptive backup support is both safe and effective, suggesting its potential for use in other ventilation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive mechanical backup ventilation for preterm infants on respiratory assist modes - a pilot study. Herber-Jonat, S., Rieger-Fackeldey, E., Hummler, H., et al.[2018]

In a study involving 13 patients with chronic neuromuscular disease, three noninvasive ventilation modes (assist/controlled ventilation, assist pressure-controlled ventilation, and pressure-support ventilation) were found to similarly improve alveolar ventilation and reduce respiratory effort.

While pressure-support ventilation showed higher inspiratory peak flow and more triggered cycles compared to volume-limited ventilation, overall, there were no significant differences in breathing effectiveness among the three modes, indicating that any of these options could be suitable for patients needing noninvasive ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure support versus assisted controlled noninvasive ventilation in neuromuscular disease. Chadda, K., Clair, B., Orlikowski, D., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

A comparison of volume control and pressure-regulated volume control ventilation in acute respiratory failure. [2022]

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

A Pragmatic Pilot Trial Comparing Patient-Triggered Adaptive Pressure Control to Patient-Triggered Volume Control Ventilation in Critically Ill Adults. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Pressure Regulated Volume Control (PRVC): Set it and forget it? [2020]

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

Patient comfort during pressure support and volume controlled-continuous mandatory ventilation. [2008]

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

Pressure-regulated volume control ventilation vs synchronized intermittent mandatory ventilation for very low-birth-weight infants: a randomized controlled trial. [2007]

6. Spain pubmed.ncbi.nlm.nih.gov

[Control and assist-control modes of mechanical ventilation]. [2019]

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

Patient-ventilator interaction during the triggering phase. [2005]

8. England pubmed.ncbi.nlm.nih.gov

Randomised weaning trial comparing assist control to pressure support ventilation. [2022]

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

Adaptive mechanical backup ventilation for preterm infants on respiratory assist modes - a pilot study. [2018]

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

Pressure support versus assisted controlled noninvasive ventilation in neuromuscular disease. [2018]