← Back to Search

Vasodilator

Electrical Impedance Tomography for Ventilation Perfusion Mismatch

N/A

Recruiting

Led By Maurizio Cereda, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after ino. subsequent days up to 28 days will be determined by the critical care staff

Awards & highlights

Study Summary

This trial aims to study a condition called Acute Respiratory Distress Syndrome (ARDS), where the lungs become inflamed due to various reasons like infection or trauma. Often, people with ARDS need

Who is the study for?

This trial is for adults over 18 who are in the ICU, intubated and on a ventilator due to mild to moderate ARDS. They must have an arterial line and central line already in place.Check my eligibility

What is being tested?

The study tests if inhaling nitric oxide (iNO) improves blood flow in the lungs of ARDS patients using Electrical Impedance Tomography (EIT), compared with dual-energy computed tomography (DECT).See study design

What are the potential side effects?

Inhaled nitric oxide may cause headaches, dizziness, or low blood pressure. It can also lead to airway inflammation or worsen lung function if not properly administered.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after ino. subsequent days up to 28 days will be determined by the critical care staff

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after ino. subsequent days up to 28 days will be determined by the critical care staff

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, arterial blood gas samples will be taken at two time points: before and 1 hour after ino. subsequent days up to 28 days will be determined by the critical care staff for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in regional lung perfusion after the delivery of inhaled nitric oxide

Secondary outcome measures

Compare methods to detect change in regional lung perfusion after the delivery of inhaled nitric oxide

Other outcome measures

Age

Apache II score

Arterial blood pressure, central venous pressure, pulmonary artery pressure

+22 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Electrical Impedance Tomography and Dual-Energy Computed TomographyExperimental Treatment1 Intervention

In a subset of 10 subjects (cohort 2), EIT and DECT will be performed in a row at the same type of bed and body position. In cohort 2, the measurements will be before nitric oxide (iNO) and during iNO. The OFF-ON fashion for DECT imaging is to minimize the subject's exposure to radiation and reduce the time spent in the CT room.

Group II: Electrical Impedance TomographyExperimental Treatment1 Intervention

A total of 60 subjects (cohort 1) will receive an inhaled nitric oxide (iNO) challenge (20 ppm) for 15 min. The investigators will measure ventilation and perfusion distributions using EIT before iNO ("OFF1"), after 15 min on iNO ("ON"), and after 15 min washout ("OFF2") to confirm baseline stability.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitric Oxide

2004

Completed Phase 4

~1280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,571 Total Patients Enrolled

Maurizio Cereda, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

419 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals older than 75 years being included in the patient recruitment for this study?

"Participants must be between 18 and 80 years old to meet the enrollment criteria for this trial."

Answered by AI

What is the current number of individuals receiving medical care as part of this research project?

"Indeed, details on clinicaltrials.gov indicate that this research initiative is actively seeking participants. Originally listed on November 1st, 2023 and recently revised on March 26th, 2024, the trial aims to enroll a total of 70 patients from a single location."

Answered by AI

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, details on clinicaltrials.gov affirm that this investigation is actively seeking suitable candidates. The trial was initially shared on November 1st, 2023 and most recently revised on March 26th, 2024. Approximately seventy participants are sought from a single designated site."

Answered by AI

Which individuals meet the criteria for eligibility to take part in this medical study?

"To be considered for this research, 70 individuals aged between 18 and 80 with ventilation perfusion mismatch are sought. Eligible participants must meet the subsequent requirements: Adult patients intubated and receiving mechanical ventilation (≥ 18 years old) who have been admitted to the intensive care unit (ICU), diagnosed with ARDS exhibiting mild to moderate severity as per Berlin criteria1 (100 mmHg < PaO2/FiO2 ≤ 300 mmHg), equipped with an arterial line for blood gas measurement and blood pressure monitoring, along with a central line in place for hypertonic saline administration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vascular ARDS Recruitment After Inhaled Nitric Oxide

Maurizio F. Cereda, MD 2023. "Vascular ARDS Recruitment After Inhaled Nitric Oxide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05801224.

All > Ards