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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of mechanical ventilation affect muscle strength and breathing recovery in ventilator users. It compares two ventilation modes: Assist Control Mode Mechanical Ventilation, which fully controls breathing rate and volume, and Volume Support Mode Mechanical Ventilation, which adjusts support based on the patient's breathing efforts. The goal is to determine which method reduces ventilator time and prevents muscle weakening, particularly in the diaphragm, the main muscle used for breathing. Individuals who have been on a ventilator for less than 36 hours may be suitable for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve ventilator care.

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 prior data suggests that these mechanical ventilation modes are safe for preventing muscle wasting?

Research has shown that volume support mode and assist control mode are common types of mechanical ventilation used in hospitals. These methods are crucial for patients needing breathing assistance. Mechanical ventilation can save lives for those with respiratory problems.

Volume support mode aids patients in breathing independently by assisting each breath to reach a specific lung volume. This method is usually comfortable for patients because it adjusts to their breathing efforts.

Assist control mode is often used in intensive care units. It provides a steady breathing rate and volume, ensuring patients receive enough air even if they cannot breathe independently. This mode has proven effective in treating conditions like acute respiratory distress syndrome (ARDS) and is considered safe.

In summary, both ventilation modes are well-established in medical care and have a history of safe use in hospitals. They are generally well-tolerated and are part of standard care for patients with serious breathing issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these ventilation modes because they offer unique strategies to prevent muscle wasting in patients requiring mechanical ventilation. Unlike traditional modes that often set fixed parameters, Volume Support Mode allows patients to breathe spontaneously with the ventilator adjusting support to reach a target volume, potentially enhancing comfort and reducing muscle strain. Assist Control Mode, in contrast, ensures consistent delivery of a set tidal volume and respiratory rate, providing stability and reducing the workload on patients’ respiratory muscles. These approaches aim to optimize breathing support while minimizing muscle deterioration, potentially improving recovery outcomes.

What evidence suggests that these ventilation modes are effective for preventing muscle wasting?

This trial compares two methods of mechanical ventilation to prevent muscle wasting and improve lung function. The first method, volume support mode, allows patients to breathe independently while the machine adjusts to help them reach a set air volume, which can help maintain muscle strength. Research suggests this method may reduce the need for sedatives and improve air distribution in the lungs. The second method, assist control mode, is commonly used in intensive care units. It provides a fixed air volume with each breath and has lowered death rates in patients with ARDS, a serious lung condition. Both methods in this trial aim to maintain muscle strength while assisting with breathing. ^{1 2 3 4 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539742/

Mechanical Ventilation - StatPearls - NCBI Bookshelf [2] Mechanical ventilation can be administered through various modes, including mandatory or assisted modes. In the assisted mode, the patient's inspiratory ...

2. withpower.com withpower.com/trial/phase-atrophy-2-2019-6a48b

Mechanical Ventilation Modes for Preventing Muscle Wasting The objective of the study is to determine how controlled mode ventilation and support mode ventilation impact ventilator-free days and diaphragmatic atrophy.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK441856/

Assist-Control Ventilation - StatPearls - NCBI Bookshelf - NIH Assist-control ventilation is the most common setting used in the ICU and is the only setting with proven mortality benefits in patients with ARDS.

4. publications.ersnet.org publications.ersnet.org/content/erj/20/4/925

Different modes of assisted ventilation in patients with acute ... It can reduce the need for sedation and paralysis, decrease the risk of barotrauma 2, improve intrapulmonary gas distribution 3, and prevent muscle atrophy 4, 5 ...

5. emedicine.medscape.com emedicine.medscape.com/article/304068-overview

Mechanical Ventilation Assist-control differs from controlled ventilation because the patient can trigger the ventilator to deliver a breath and, thereby, adjust their ...

6. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(17)30324-5/fulltext

Mechanical Ventilation: State of the Art This state-of-the-art review provides an update on the basic physiology of respiratory mechanics, the working principles, and the main ventilatory settings.