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Vasodilator

Inhaled Nitric Oxide for Cardiac Arrest (iNOCAPA Trial)

Phase 2

Recruiting

Led By Jamie Hutchison, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up we will monitor compliance to the study intervention during the 72 hours of drug/sham delivery and 12 hours of weaning and stopping the study intervention on each enrolled patient over the 2 years of study enrolment.

Awards & highlights

iNOCAPA Trial Summary

This trial tests how inhaled nitric oxide affects cardiac arrest patients during CPR, and if it can improve survival.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of inhaled nitric oxide aren't listed here, it can generally cause issues like headache, dizziness, nausea or vomiting. In some cases, it might affect blood pressure or breathing.

iNOCAPA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ we will monitor compliance to the study intervention during the 72 hours of drug/sham delivery and 12 hours of weaning and stopping the study intervention on each enrolled patient over the 2 years of study enrolment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~we will monitor compliance to the study intervention during the 72 hours of drug/sham delivery and 12 hours of weaning and stopping the study intervention on each enrolled patient over the 2 years of study enrolment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and we will monitor compliance to the study intervention during the 72 hours of drug/sham delivery and 12 hours of weaning and stopping the study intervention on each enrolled patient over the 2 years of study enrolment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Drug Procedural Feasibility

Secondary outcome measures

Monitor masking and unmasking events

Monitor recruitment rate

Monitor time to randomization of eligible patients

+1 more

Other outcome measures

Blood protein biomarkers

Cerebral performance category score

Quality of Life Score

+3 more

Side effects data

From 2011 Phase 2 & 3 trial • 21 Patients • NCT00945529

30%

Pleural effusion requiring drainage

22%

prolonged hospital stay due to infection

17%

Prolonged hospital stay due to pleural effusion

Prolonged hospital stay due to seizures

Prolonged hospital stay due to SVT

100%

80%

60%

40%

20%

Study treatment Arm

No Intervention/ Historical Control Group

Intervention

iNOCAPA Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

inhaled nitric oxide (iNO)

2008

Completed Phase 3

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Heart and Stroke Foundation of CanadaOTHER

123 Previous Clinical Trials

72,144 Total Patients Enrolled

7 Trials studying Cardiac Arrest

5,663 Patients Enrolled for Cardiac Arrest

The Hospital for Sick ChildrenLead Sponsor

690 Previous Clinical Trials

6,945,438 Total Patients Enrolled

2 Trials studying Cardiac Arrest

494 Patients Enrolled for Cardiac Arrest

Jamie Hutchison, MDPrincipal InvestigatorThe Hospital for Sick Children

1 Previous Clinical Trials

38 Total Patients Enrolled

1 Trials studying Cardiac Arrest

38 Patients Enrolled for Cardiac Arrest

Media Library

Inhaled Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05868109 — Phase 2

Cardiac Arrest Research Study Groups: Participants with Sham (no nitric oxide), Participants with Nitric Oxide

Cardiac Arrest Clinical Trial 2023: Inhaled Nitric Oxide Highlights & Side Effects. Trial Name: NCT05868109 — Phase 2

Inhaled Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05868109 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical research have any age restrictions for participants?

"This medical experiment is open to people between the ages of 1 Day and 80 years."

Answered by AI

Are there any restrictions on enrolling in this experiment?

"To be eligible for inclusion in this study, patients must have experienced a cardiac arrest and fall between one day old to 80 years of age. 40 individuals are set to take part in the trial."

Answered by AI

Is recruitment still available for this clinical investigation?

"According to the clinicaltrials.gov records, this medical research is enrolling new participants as of now; it was initially posted on August 31st 2022 and recently updated on May 11th 2023."

Answered by AI

Is the use of nitric oxide for medicinal purposes accepted by the FDA?

"After careful consideration, the safety rating of Nitric Oxide was determined to be a 2. This is because this Phase 2 trial has collected some evidence supporting its security but nothing documenting efficacy."

Answered by AI

How extensive is the enrollment for this research endeavor?

"Affirmative, the information found on clinicaltrials.gov states that this investigation is proactively searching for prospects. This trial was originally listed on August 31st 2022 and has been recently updated May 11th 2023. The study seeks to recruit 40 individuals from 4 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA)

Jamie Hutchison 2022. "Inhaled Nitric Oxide for Cardiac Arrest in Pediatrics and Adults (iNOCAPA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05868109.

All > Cardiac Arrest