Nasogastric Balloon for Respiratory Function

(VIREM Trial)

Recruiting at 2 trial locations

Overseen By Marquez

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University Hospital, Antwerp

Disqualifiers: Recent ventilation, Diaphragm malformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how a small device, called a nasogastric balloon, can protect the lungs and diaphragm during mechanical ventilation. It targets intensive care patients who need machine-assisted breathing for more than two days. Researchers seek to determine if gentle breathing efforts with this device maintain muscle function without damaging the lungs. Suitable candidates are over 28 days old, weigh more than 3 kg, and are already on a ventilator. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future care for those requiring mechanical ventilation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the placement of a nasogastric balloon is safe for respiratory function assessment?

Research has shown that using a nasogastric balloon, similar to a nasogastric tube, can be risky if not placed correctly. A nasogastric tube is a flexible tube inserted through the nose into the stomach. Improper positioning may lead it to enter the lungs instead of the stomach, posing significant danger.

Studies have found that incorrect placement of nasogastric tubes can cause breathing problems, highlighting the importance of careful placement. Patients might experience discomfort during the procedure, but proper preparation can ease the process.

Generally, nasogastric balloons are safe when used correctly, but improper handling poses a risk of harm. Employing the right technique and paying close attention during placement are essential to prevent complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nasogastric balloon for respiratory function because it offers a novel approach to improving breathing. Unlike standard treatments that often involve medication or invasive procedures, this technique involves the strategic placement of a balloon in the nasogastric area to aid respiratory function directly. This method has the potential to provide immediate relief and could be less invasive, reducing the risk of complications associated with more traditional respiratory treatments. By targeting the mechanics of breathing, it opens up a new avenue for managing respiratory issues more effectively.

What evidence suggests that the placement of a nasogastric balloon is effective for respiratory function?

Research has shown that special balloons inserted through a tube in the nose can help doctors assess the function of breathing muscles and lungs. These balloons measure pressure in the esophagus, providing insights into the lungs and the diaphragm, the primary muscle for breathing. Early results suggest that taking smaller breaths might maintain diaphragm function without harming the lungs. Although inserting a tube from the nose to the stomach can occasionally cause issues, careful use can yield valuable information. Overall, these balloons are expected to enhance doctors' understanding and management of breathing in ICU patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Tom Schepens, M.D., Ph.D.

Principal Investigator

PICU staff member

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I need a machine to help me breathe.

You are expected to need a ventilator for more than 48 hours.

I am older than 28 days.

Exclusion Criteria

I have not refused to give my consent for the trial.

I cannot have a tube placed through my nose into my stomach.

I have been on a breathing machine for no more than 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo daily measurements of esophageal pressures and ultrasound assessments during mechanical ventilation

8 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placement of nasogastric balloon

Trial Overview 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.

How Is the Trial Designed?

Group I: Overall group Experimental Treatment 1 Intervention

Placement of a nasogastric balloon

Who Is Running the Clinical Trial?

University Hospital, Antwerp

Lead Sponsor

Trials

328

Recruited

135,000+

Universiteit Antwerpen

Collaborator

Trials

241

Recruited

333,000+

Research Foundation Flanders

Collaborator

Trials

89

Recruited

37,700+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Universitaire Ziekenhuizen KU Leuven

Collaborator

Trials

1,048

Recruited

1,658,000+

KU Leuven

Collaborator

Trials

587

Recruited

200,340,000+

Universitaire Ziekenhuizen Leuven

Collaborator

Trials

850

Recruited

1,233,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Published Research Related to This Trial

Nasogastric tubes are useful for short-term feeding when oral intake isn't possible, but their insertion carries risks, including potential misplacement into the lungs.

A case is highlighted where a nasogastric tube was incorrectly positioned in both main bronchi, emphasizing the need for a chest x-ray after placement to prevent serious respiratory complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadvertent insertion of a nasogastric tube into both main bronchi of an awake patient: a case report. Takwoingi, YM.[2021]

A review of 69 studies found that adverse events related to nasogastric/nasoenteric tubes are common, with a significant number leading to respiratory complications, increased hospital stays, and even death.

The findings highlight the need for healthcare professionals, particularly nurses, to create evidence-based guidelines for the safe insertion and positioning of these tubes to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasogastric/nasoenteric tube-related adverse events: an integrative review. Motta, APG., Rigobello, MCG., Silveira, RCCP., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-respiratory-function-tests-7-2022-c4ad7?condition=&query=Lung+Ultrasound&overallStatus=Recruiting&hasNoPlacebo=false

Nasogastric Balloon for Respiratory Function (VIREM Trial) The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7798396/

Nasogastric/nasoenteric tube-related adverse events Nasogastric/nasoenteric tube related adverse events are relatively common and the majority involved respiratory harm that resulted in increased hospitalization ...

3. researchgate.net researchgate.net/publication/259530258_Assessing_Respiratory_Function_Depends_on_Mechanical_Characteristics_of_Balloon_Catheters

Assessing Respiratory Function Depends on Mechanical ... Background: Respiratory muscle function and lung and chest wall mechanics are reliably assessed by esophageal and gastric balloon catheters.

4. emedicine.medscape.com emedicine.medscape.com/article/80925-overview

Nasogastric Intubation: Background, Indications, ... Nasogastric intubation is a procedure using a tube to access the stomach for diagnostic and therapeutic purposes, such as evaluating GI ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0964339725000953

Application of pressure at the gastric tube tip manometry for ... To evaluate the accuracy of pressure at the gastric tube tip manometry for confirming nasogastric (NG) tube placement in neurocritical care patients.

6. bapen.org.uk bapen.org.uk/pdfs/ngsig/a-position-paper-on-nasogastric-tube-safety-v2.pdf

A Position Paper on Nasogastric Tube Safety This document will focus on Never Events including misplacement into the pulmonary tree and into the pleural space with or without pneumothorax. It is not clear ...

7. hssib.org.uk hssib.org.uk/patient-safety-investigations/placement-of-nasogastric-tubes/investigation-report/

Investigation report: Placement of nasogastric tubes There is a risk of serious harm and risk to life if NG tubes are incorrectly placed into the lungs rather than the stomach and fluid, medicine ...