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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.
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.
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.
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.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Drug Procedural Feasibility
Secondary study objectives
Monitor masking and unmasking events
Monitor recruitment rate
Monitor time to randomization of eligible patients
+1 moreOther study objectives
Blood protein biomarkers
Cerebral performance category score
Quality of Life Score
+3 moreSide effects data
From 2011 Phase 2 & 3 trial • 21 Patients • NCT0094552930%
Pleural effusion requiring drainage
22%
prolonged hospital stay due to infection
17%
Prolonged hospital stay due to pleural effusion
4%
Prolonged hospital stay due to seizures
4%
Prolonged hospital stay due to SVT
100%
80%
60%
40%
20%
0%
Study treatment Arm
No Intervention/ Historical Control Group
Intervention
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
Find a Location
Who is running the clinical trial?
Heart and Stroke Foundation of CanadaOTHER
130 Previous Clinical Trials
72,751 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
712 Previous Clinical Trials
6,959,696 Total Patients Enrolled
Jamie Hutchison, MDPrincipal InvestigatorThe Hospital for Sick Children
1 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need iNO therapy after a cardiac arrest.I can start the trial treatment during CPR or within 5 hours after my heart starts again.I had a heart attack that no one saw.I am currently on inhaled nitric oxide treatment.I had a cardiac arrest caused by lack of oxygen at birth.I am currently on a ventilator in the ICU.My CPR lasted more than 45 minutes; if under 18, it was over 60 minutes in a hospital.I had a cardiac arrest and received CPR for more than 5 minutes.I am between 1 day and 80 years old.I do not have any health conditions that would worsen with iNO treatment.I had significant brain function issues before a cardiac arrest.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Sham (no nitric oxide)
- Group 2: Participants with Nitric Oxide
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.