Protective Measures + Paralysis + Proning for Acute Respiratory Distress Syndrome

Not currently recruiting at 16 trial locations

Overseen By Ken K Parhar, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

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

Compensation: Varies

Number of Visits: Unknown

Duration: 29 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve care for patients with severe breathing problems, specifically those with Hypoxemic Respiratory Failure (HRF) and Acute Respiratory Distress Syndrome (ARDS). It focuses on a new treatment pathway called TheraPPP, which includes protective measures, muscle relaxation, and positioning to help these patients breathe better. The trial will occur in 17 Intensive Care Units in Alberta and is open to patients on mechanical ventilators. The study evaluates the effectiveness of the TheraPPP Pathway and its applicability in real-world settings. As an unphased trial, it offers patients the chance to contribute to innovative care solutions that could enhance treatment for severe respiratory conditions.

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 the TheraPPP Pathway is safe for patients with HRF and ARDS?

Research shows that the TheraPPP Pathway is designed to improve care for patients with breathing problems like Acute Respiratory Distress Syndrome (ARDS). The pathway focuses on three main actions: protective measures, temporarily relaxing the muscles, and turning patients onto their stomachs to aid breathing.

The study examines how well patients handle these treatments in terms of safety. Although specific safety data from the TheraPPP Pathway is not detailed, similar methods are commonly used in medical care and are generally well-tolerated. The pathway organizes these treatments based on existing evidence, indicating that the risks are manageable and understood.

Overall, the TheraPPP Pathway is expected to have manageable side effects, as it builds on treatments already used in hospitals. This suggests it is unlikely to introduce new risks beyond those typically experienced in similar medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TheraPPP pathway for Acute Respiratory Distress Syndrome (ARDS) because it combines protective measures, paralysis, and proning in a novel way. While current treatments typically focus on mechanical ventilation and specific drug interventions, TheraPPP integrates these three strategies into a coordinated pathway, aiming to improve patient outcomes more effectively. This approach not only targets lung protection and oxygenation but also evaluates the practical implementation and acceptability among clinicians, which could lead to broader adoption if successful. The comprehensive nature of this pathway promises to address ARDS from multiple angles, potentially setting a new standard in care.

What evidence suggests that the TheraPPP Pathway is effective for treating Acute Respiratory Distress Syndrome?

The TheraPPP pathway, evaluated in this trial, employs protective measures, temporary muscle relaxation, and prone positioning to assist patients with Acute Respiratory Distress Syndrome (ARDS) and Hypoxemic Respiratory Failure (HRF). Research suggests these methods can enhance patient outcomes by improving care for those on ventilators. This approach relies on evidence, using the best available research to guide treatment. While the trial tests the TheraPPP pathway's effectiveness and implementation, these individual strategies have already proven beneficial for patients with ARDS and HRF. Overall, TheraPPP aims to standardize and enhance the quality of care for patients with these serious respiratory issues. ^{3 5 6 7 8}

Who Is on the Research Team?

Ken K Parhar, MD, MSc

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for patients in any of the 17 adult Intensive Care Units in Alberta who are on invasive mechanical ventilation due to severe respiratory issues like ARDS or hypoxemic respiratory failure. There are no specific exclusion criteria, so a wide range of patients with these conditions can participate.

Inclusion Criteria

Admitted to one of the 17 adult Intensive Care Units in Alberta

You are receiving help breathing with a machine.

Exclusion Criteria

It seems like there is no specific criterion provided in this case. If you need any further assistance, feel free to ask!

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of the TheraPPP Pathway for mechanically ventilated patients in the ICU

29 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• TheraPPP

Trial Overview The TheraPPP Pathway is being tested to see if it improves care for patients with acute respiratory problems. It involves evidence-based treatments including protection (lung-protective ventilation), paralysis (medication-induced), and proning (lying face down) to help breathing.

How Is the Trial Designed?

Group I: TheraPPP Pathway Experimental Treatment 1 Intervention

The investigators will perform an effectiveness-implementation hybrid study design (type 1) to evaluate the effectiveness and implementation of the TheraPPP pathway. All mechanically ventilated patients admitted to the ICU will enter the pathway. To evaluate effectiveness the investigators will collect patient data for approximately 29 months. To assess acceptability of the pathway the investigators will conduct a survey and focus groups to clinicians who used the Pathway.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

In a study of 100 neonates with neonatal respiratory distress syndrome (NRDS), nasal intermittent positive pressure ventilation (NIPPV) was found to be more effective than nasal continuous positive airway pressure (NCPAP) in reducing CO2 retention and improving oxygenation within the first 6 hours of treatment.

NIPPV also resulted in significantly lower rates of second endotracheal intubation and reduced the need for additional pulmonary surfactant, indicating its potential to improve overall respiratory support outcomes in neonates with NRDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical application of nasal intermittent positive pressure ventilation in initial treatment of neonatal respiratory distress syndrome]. Fu, CH., Xia, SW.[2014]

Lung-protective mechanical ventilation is a safe and potentially beneficial strategy for patients without acute respiratory distress syndrome (ARDS), based on observational data and systematic reviews.

This ventilation approach includes specific principles such as using lower tidal volumes (4 to 8 ml/kg), maintaining plateau pressures below 30 cmH2O, and ensuring adequate oxygen levels, making it suitable for both perioperative and critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial ventilator settings for critically ill patients. Kilickaya, O., Gajic, O.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38234326/

A type-1 hybrid stepped-wedge cluster randomised ... TheraPPP is a stepped-wedge cluster randomised study evaluating a care pathway for HRF and ARDS patients. This is a type-1 hybrid effectiveness-implementation ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1441277223022196

Protocol and statistical analysis plan for the identification ... TheraPPP is a stepped-wedge cluster randomised study evaluating a care pathway for HRF and ARDS patients. This is a type-1 hybrid effectiveness-implementation ...

3. nature.com nature.com/articles/s41392-025-02127-9

Advances in acute respiratory distress syndrome However, there is no significant difference in overall hospital mortality between men (40.2%) and women (40.2%), although women have been ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04744298

Identification and Treatment of Hypoxemic Respiratory ... The TheraPPP pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of HRF.

5. withpower.com withpower.com/trial/phase-paralysis-3-2021-e0808

Protective Measures + Paralysis + Proning for Acute ... What data supports the effectiveness of the treatment TheraPPP for Acute Respiratory Distress Syndrome? The research suggests that combining several ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790012/

A type-1 hybrid stepped-wedge cluster randomised ... We estimate a sample size of 18816 mechanically ventilated patients, with 11424 patients preimplementation and 7392 patients postimplementation.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04070053

Treatment of Hypoxemic Respiratory Failure and ARDS ... The TheraPPP pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of HRF.

8. medrxiv.org medrxiv.org/content/10.1101/2023.03.17.23287218v1.full.pdf

Statistical analysis plan for the Identification and Treatment ... Epidemiology, Mechanical. Power, and 3-Year Outcomes in Acute Respiratory Distress Syndrome Patients Using Standardized. Screening. An ...