40 Participants Needed

Inhaled Nitric Oxide for Cardiac Arrest

(iNOCAPA Trial)

Recruiting at 3 trial locations
JH
JH
JG
Overseen ByJohn Granton, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a multi-center, double blind, randomized controlled trial of inhaled nitric oxide (iNO) in children and adults with cardiac arrest (CA). The purpose of this pilot study is to test the feasibility of rapidly randomizing patients to iNO or sham treatment during cardiopulmonary resuscitation (CPR) or shortly after return of circulation (ROC) and evaluate blood biomarkers associated with iNO compared to sham. Return of circulation may refer to return of spontaneous circulation (ROSC) or ROC through extracorporeal cardiopulmonary resuscitation (E-CPR).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug inhaled nitric oxide unique for treating cardiac arrest?

Inhaled nitric oxide (iNO) is unique because it is administered directly into the lungs to improve oxygenation and reduce pulmonary arterial pressure, which is different from other treatments for cardiac arrest that may not target the lungs directly. While it has shown benefits in animal models for cardiac arrest, its impact on humans with cardiac arrest is still being studied.12345

What data supports the effectiveness of the treatment Inhaled Nitric Oxide for cardiac arrest?

Inhaled nitric oxide (iNO) has been shown to improve outcomes in animal studies when given during cardiopulmonary resuscitation (CPR) after cardiac arrest, increasing the success of resuscitation and improving survival rates. Additionally, iNO is known to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in newborns with severe respiratory failure.14567

Who Is on the Research Team?

JH

Jamie Hutchison, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for children and adults aged 1 day to 80 years who've had a cardiac arrest and are on mechanical ventilation in the ICU. They must be able to start treatment during CPR or within 5 hours after circulation returns. Excluded are those with pre-arrest poor brain function, already on iNO, certain heart conditions, long CPR duration (>45 minutes), known pregnancy, or terminal illness.

Inclusion Criteria

I can start the trial treatment during CPR or within 5 hours after my heart starts again.
I am currently on a ventilator in the ICU.
I had a cardiac arrest and received CPR for more than 5 minutes.
See 1 more

Exclusion Criteria

I need iNO therapy after a cardiac arrest.
Known pregnancy
I had a heart attack that no one saw.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 hours
1 visit (in-person)

Treatment

Participants receive inhaled nitric oxide or sham treatment during chest compressions or shortly after return of circulation for 72 hours, followed by a 12-hour weaning period

3.5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 and 6 months following cardiac arrest

6 months
Multiple visits (in-person and virtual)

Biomarker Analysis

Blood samples are collected and analyzed for biomarkers at multiple time points post-enrollment

7 days

What Are the Treatments Tested in This Trial?

Interventions

  • Inhaled Nitric Oxide
  • Sham
Trial Overview The study tests if inhaling nitric oxide (iNO) helps patients during or just after a cardiac arrest compared to a sham (fake treatment). It's randomized and double-blind, meaning neither the participants nor the researchers know who gets real iNO until after the results are collected.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants with Nitric OxideExperimental Treatment1 Intervention
The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device and nitric oxide is delivered.
Group II: Participants with Sham (no nitric oxide)Placebo Group1 Intervention
The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device but nitric oxide is not delivered.

Inhaled Nitric Oxide is already approved in United States, European Union for the following indications:

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Approved in United States as INOmax for:
  • Hypoxic respiratory failure
  • Pulmonary hypertension
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Approved in United States as Genosyl for:
  • Hypoxic respiratory failure
  • Pulmonary hypertension
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Approved in European Union as INOmax for:
  • Persistent pulmonary hypertension of the newborn
  • Acute hypoxic respiratory failure

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials
131
Recruited
72,600+

Published Research Related to This Trial

Inhaled nitric oxide (iNO) can improve oxygenation in critically ill patients with pulmonary hypertension and respiratory failure, but it does not improve survival rates, as shown in a study of 215 patients from 2004 to 2009.
Key predictors of mortality in patients receiving iNO include worsening Sequential Organ Failure Assessment scores, higher Charlson Comorbidity Scores, and increased methaemoglobin levels, indicating that while iNO may help with oxygenation, its use as a routine treatment in severe cases is not justified.
'Safe' methaemoglobin concentrations are a mortality risk factor in patients receiving inhaled nitric oxide.Rolley, L., Bandeshe, H., Boots, RJ.[2019]
Inhaled nitric oxide (iNO) significantly improved oxygen levels in patients with severe hypoxemia, with arterial oxygen partial pressure (PaO2) increasing from 60.7 to 72.3 mm Hg after treatment (P=.008).
The use of iNO allowed for safe transport of patients to a tertiary care center, with 60.2% of those treated surviving to discharge, compared to a 50% survival rate in patients transported without iNO.
Inhaled nitric oxide to improve oxygenation for safe critical care transport of adults with severe hypoxemia.Teman, NR., Thomas, J., Bryner, BS., et al.[2020]
Inhaled nitric oxide (iNO) can be safely managed by trained nurses during the transport of critically ill patients, as demonstrated by a study involving patients transported from March 2020 to August 2022.
Out of the patients studied, only 16.7% experienced hypotension, which was manageable and resolved with medication adjustments, while no serious adverse events like worsening hypoxemia or cardiac arrest were reported.
Safety of Nurse-Managed Inhaled Nitric Oxide During Critical Care Interfacility Transport.Troncoso, R., Garfinkel, EM., Kaul, K., et al.[2023]

Citations

'Safe' methaemoglobin concentrations are a mortality risk factor in patients receiving inhaled nitric oxide. [2019]
Inhaled nitric oxide to improve oxygenation for safe critical care transport of adults with severe hypoxemia. [2020]
Safety of Nurse-Managed Inhaled Nitric Oxide During Critical Care Interfacility Transport. [2023]
A randomized trial of early versus standard inhaled nitric oxide therapy in term and near-term newborn infants with hypoxic respiratory failure. [2019]
Brief inhalation of nitric oxide increases resuscitation success and improves 7-day-survival after cardiac arrest in rats: a randomized controlled animal study. [2018]
Inhaled nitric oxide in adults with in-hospital cardiac arrest: A feasibility study. [2022]
A Quality Improvement Initiative to Standardize Use of Inhaled Nitric Oxide in the PICU. [2022]
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