Protective Measures + Paralysis + Proning for Acute Respiratory Distress Syndrome

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

19916 Participants Needed

Trial Summary

What is the purpose of this trial?

Treatment of patients with Hypoxemic respiratory failure (HRF) and Acute Respiratory Distress Syndrome (ARDS) is complex. Therapies that have been shown to save the lives of patients with HRF and ARDS are available but they are not always provided. To reduce practice variation and improve adherence to evidence-informed therapies, the investigators developed the Treatment of Hypoxemic Respiratory Failure and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway. The overall objective of TheraPPP Pathway is to improve the quality of care for patients with HRF. Implementation of the pathway across Alberta will test the effectiveness and implementation of the TheraPPP Pathway.

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 TheraPPP for Acute Respiratory Distress Syndrome?

The research suggests that combining several treatment methods, like protective ventilatory strategies, prone positioning, and early short-term paralysis, can improve outcomes in patients with acute respiratory distress syndrome by enhancing oxygenation and reducing mortality. ^{1 2 3 4 5}

Is the treatment Protective Measures + Paralysis + Proning for ARDS generally safe for humans?

Lung-protective ventilation, a part of this treatment, has been used safely for over a decade in patients with and without ARDS, according to observational data and studies. ^{6 7 8 9 10}

How is the TheraPPP treatment different from other treatments for acute respiratory distress syndrome?

TheraPPP is unique because it combines protective measures, paralysis, and proning, which are strategies used to improve breathing in patients with acute respiratory distress syndrome. This approach is distinct as it integrates these elements to potentially enhance gas exchange and reduce lung injury, unlike traditional treatments that may not use all these components together. ^{11 12 13 14 15}

Research Team

Ken K Parhar, MD, MSc

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Acute respiratory distress syndrome of the adult: are there new therapeutic approaches?]. [2020]

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

Pressure Injury Prevention in Patients in Prone Position With Acute Respiratory Distress Syndrome and COVID-19. [2023]

3. Egypt pubmed.ncbi.nlm.nih.gov

Goal-oriented respiratory management for critically ill patients with acute respiratory distress syndrome. [2021]

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

Trauma-adult respiratory distress syndrome. [2020]

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

Long-term follow-up of survivors of acute lung injury: lack of effect of a ventilation strategy to prevent barotrauma. [2020]

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

Mechanical Stress and the Induction of Lung Fibrosis via the Midkine Signaling Pathway. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Prophylactic treatment in the adult respiratory distress syndrome. [2020]

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

Preventing the acute respiratory distress syndrome. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Initial ventilator settings for critically ill patients. [2021]

10. China pubmed.ncbi.nlm.nih.gov

[Clinical application of nasal intermittent positive pressure ventilation in initial treatment of neonatal respiratory distress syndrome]. [2014]

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

Proning in COVID-19 Acute Respiratory Distress Syndrome: Role of Paralytics. [2022]

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

Low stretch ventilation strategy in acute respiratory distress syndrome: eight years of clinical experience in a single center. [2022]

13. Japan pubmed.ncbi.nlm.nih.gov

[Ventilatory strategy for ARDS]. [2020]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Risk Factors Analysis of Thoracic Trauma Complicated With Acute Respiratory Distress Syndrome and Observation of Curative Effect of Lung-Protective Ventilation. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Airway pressure release ventilation and prone positioning in severe acute respiratory distress syndrome. [2020]