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Nasogastric Balloon for Respiratory Function (VIREM Trial)

N/A

Recruiting

Research Sponsored by University Hospital, Antwerp

Eligibility Criteria Checklist

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

Must have

Requiring invasive mechanical ventilation

Age > 28 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months

Awards & highlights

VIREM Trial Summary

This trial will study the effects of a patient's inspiratory effort on their lungs and diaphragm.

Who is the study for?

This trial is for ICU patients who need help breathing with a machine and expect to be on it for more than 48 hours. They must be older than 28 days, weigh over 3kg, and consent to participate. It's not suitable for those who've been ventilated in the last two weeks or have diaphragm malformations.Check my eligibility

What is being tested?

The study tests how controlling the effort of breathing while on a ventilator affects lung and diaphragm health. Patients will have their esophageal pressures measured using a special balloon catheter and undergo daily ultrasound checks of their lungs and diaphragm for up to eight days.See study design

What are the potential side effects?

Potential side effects may include discomfort from the nasogastric balloon placement, possible irritation or injury inside the nose or throat, risk of infection at the insertion site, and rare complications related to incorrect placement.

VIREM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need a machine to help me breathe.

Select...

I am older than 28 days.

VIREM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Tidal esophageal pressure swing (∆Pes) - D1

Tidal esophageal pressure swing (∆Pes) - D2

Tidal esophageal pressure swing (∆Pes) - D3

+5 more

Secondary outcome measures

Dead space ventilation (VD) - D1

Dead space ventilation (VD) - D2

Continuous Positive Airway Pressure

+87 more

VIREM Trial Design

1Treatment groups

Experimental Treatment

Group I: Overall groupExperimental Treatment1 Intervention

Placement of a nasogastric balloon

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Hospital, AntwerpLead Sponsor

297 Previous Clinical Trials

118,844 Total Patients Enrolled

Universiteit AntwerpenOTHER

220 Previous Clinical Trials

325,622 Total Patients Enrolled

Research Foundation FlandersOTHER

74 Previous Clinical Trials

35,610 Total Patients Enrolled

Media Library

Placement of nasogastric balloon (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05459116 — N/A

Respiratory Function Tests Research Study Groups: Overall group

Respiratory Function Tests Clinical Trial 2023: Placement of nasogastric balloon Highlights & Side Effects. Trial Name: NCT05459116 — N/A

Placement of nasogastric balloon (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05459116 — N/A

Frequently Asked Questions

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

Are there any openings left to participate in this clinical research?

"Affirmative. According to clinicaltrials.gov, this medical trial which was initially advertised on September 21st 2022 is currently recruiting participants. Approximately 150 patients need to be enrolled from a single site."

Answered by AI

What is the participant quota for this research experiment?

"Affirmative. The information hosted on clinicaltrials.gov suggests that this research project, which was first posted on September 21st 2022, is in the process of participant recruitment. 150 people are required to join from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation

2022. "Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05459116.