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

Trial Summary

What is the purpose of this trial?

This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.

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 data supports the effectiveness of the nasogastric balloon treatment for respiratory function?

Research shows that using a nasogastric tube with an oesophageal balloon can significantly reduce gastro-oesophageal reflux (backflow of stomach contents into the esophagus) and bronchoaspiration (inhalation of stomach contents into the lungs) in patients on mechanical ventilation, which may help improve respiratory function. ^{1 2 3 4 5}

Is the nasogastric balloon generally safe for humans?

Nasogastric tubes, which are similar to nasogastric balloons, can have safety issues if not placed correctly, leading to serious harm or even death if the tube enters the lungs instead of the stomach. Safety alerts and guidelines exist to prevent these errors, but they still occur, highlighting the importance of careful placement and confirmation by medical professionals. ^{3 6 7 8 9}

How does the nasogastric balloon treatment for respiratory function differ from other treatments?

The nasogastric balloon treatment is unique because it involves placing a balloon through the nose into the stomach, which is different from other respiratory treatments that typically involve medications or devices like inhalers. This method may offer a novel approach by potentially improving respiratory function through mechanical means rather than chemical or pharmacological interventions. ^{3 4 10 11 12}

Research Team

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

Principal Investigator

PICU staff member

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Preventing gastric regurgitation with a ballooned nasogastric tube. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Gastro-oesophageal reflux in mechanically ventilated patients: effects of an oesophageal balloon. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

A novel method for replacement of a blocked fine bore nasogastric tube. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Duodenal versus gastric feeding in medical intensive care unit patients: a prospective, randomized, clinical study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A scoping review of clinical practices and adherence to UK national guidance related to the placement and position confirmation of adult nasogastric feeding tubes. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

Nasogastric/nasoenteric tube-related adverse events: an integrative review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Factors associated with mechanical device-related complications in tube fed patients: A multicenter prospective cohort study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Patient safety matters: reducing the risks of nasogastric tubes. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Lung perforation by nasogastric feeding tubes. [2019]

11. Australia pubmed.ncbi.nlm.nih.gov

Nasogastric tube placement under sonographic observation: A comparison study of ultrasound and chest radiography in mechanically ventilated patients. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Efficiency and Safety of Balloon-Assisted Gastrostomy. [2021]