Placement of nasogastric balloon for Respiratory Muscles

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Hospital for Sick Children (SickKids), Toronto, Canada
Respiratory Muscles+3 More
Placement of nasogastric balloon - Device
Eligibility
Any Age
All Sexes
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Study Summary

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.

Eligible Conditions

  • Respiratory Muscles
  • Respiratory Function Tests
  • Respiration; Artificial

Treatment Effectiveness

Study Objectives

8 Primary · 90 Secondary · Reporting Duration: From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months

Day 1
Diaphragm thickening fraction (DTF) measured with ultrasound - D1
Day 2
Diaphragm thickening fraction (DTF) measured with ultrasound - D2
Day 3
Diaphragm thickening fraction (DTF) measured with ultrasound - D3
Day 4
Diaphragm thickening fraction (DTF) measured with ultrasound - D4
Day 5
Diaphragm thickening fraction (DTF) measured with ultrasound - D5
Day 6
Diaphragm thickening fraction (DTF) measured with ultrasound - D6
Day 7
Diaphragm thickening fraction (DTF) measured with ultrasound - D7
Day 8
Diaphragm thickening fraction (DTF) measured with ultrasound - D8
Day 1
End-expiratory diaphragm thickness (DTee) - D1
Day 2
End-expiratory diaphragm thickness (DTee) - D2
Day 3
End-expiratory diaphragm thickness (DTee) - D3
Day 4
End-expiratory diaphragm thickness (DTee) - D4
Day 5
End-expiratory diaphragm thickness (DTee) - D5
Day 6
End-expiratory diaphragm thickness (DTee) - D6
Day 7
End-expiratory diaphragm thickness (DTee) - D7
Day 8
End-expiratory diaphragm thickness (DTee) - D8
Month 4
ICU length of stay
Month 4
ICU readmission rate within 48 hours
Month 4
Hospital length of stay
Month 4
ICU mortality
Presence of clinical signs of muscle weakness at ICU discharge
Month 4
Hospital mortality
Presence of clinical signs of muscle weakness at hospital discharge
Month 4
Need for tracheal reintubation after tracheal extubation
Month 4
Duration to decease
Month 4
Duration of mechanical ventilation
Day 1
Lung ultrasound scores (LUSS) - D1
Day 2
Lung ultrasound scores (LUSS) - D2
Day 3
Lung ultrasound scores (LUSS) - D3
Day 4
Lung ultrasound scores (LUSS) - D4
Day 5
Lung ultrasound scores (LUSS) - D5
Day 6
Lung ultrasound scores (LUSS) - D6
Day 7
Lung ultrasound scores (LUSS) - D7
Day 8
Lung ultrasound scores (LUSS) - D8
Day 1
Maximal inspiratory pressure (MIP) - D1
Day 2
Maximal inspiratory pressure (MIP) - D2
Day 3
Maximal inspiratory pressure (MIP) - D3
Day 4
Maximal inspiratory pressure (MIP) - D4
Day 5
Maximal inspiratory pressure (MIP) - D5
Day 6
Maximal inspiratory pressure (MIP) - D6
Day 7
Maximal inspiratory pressure (MIP) - D7
Day 8
Maximal inspiratory pressure (MIP) - D8
Day 1
Occlusion pressure (P0.1) - D1
Day 2
Occlusion pressure (P0.1) - D2
Day 3
Occlusion pressure (P0.1) - D3
Day 4
Occlusion pressure (P0.1) - D4
Day 5
Occlusion pressure (P0.1) - D5
Day 6
Occlusion pressure (P0.1) - D6
Day 7
Occlusion pressure (P0.1) - D7
Day 8
Occlusion pressure (P0.1) - D8
Day 1
Esophageal pressure-time product (PTPes) - D1
Day 2
Esophageal pressure-time product (PTPes) - D2
Day 3
Esophageal pressure-time product (PTPes) - D3
Day 4
Esophageal pressure-time product (PTPes) - D4
Day 5
Esophageal pressure-time product (PTPes) - D5
Day 6
Esophageal pressure-time product (PTPes) - D6
Day 7
Esophageal pressure-time product (PTPes) - D7
Day 8
Esophageal pressure-time product (PTPes) - D8
Day 1
Inspiratory muscle pressure (Pmus) - D1
Day 2
Inspiratory muscle pressure (Pmus) - D2
Day 3
Inspiratory muscle pressure (Pmus) - D3
Day 4
Inspiratory muscle pressure (Pmus) - D4
Day 5
Inspiratory muscle pressure (Pmus) - D5
Day 6
Inspiratory muscle pressure (Pmus) - D6
Day 7
Inspiratory muscle pressure (Pmus) - D7
Day 8
Inspiratory muscle pressure (Pmus) - D8
Day 1
Dead space ventilation (VD) - D1
Day 2
Dead space ventilation (VD) - D2
Day 3
Dead space ventilation (VD) - D3
Day 4
Dead space ventilation (VD) - D4
Day 5
Dead space ventilation (VD) - D5
Day 6
Dead space ventilation (VD) - D6
Day 7
Dead space ventilation (VD) - D7
Day 8
Dead space ventilation (VD) - D8
Day 1
Transpulmonary driving pressure (ΔPL) - D1
Day 2
Transpulmonary driving pressure (ΔPL) - D2
Day 3
Transpulmonary driving pressure (ΔPL) - D3
Day 4
Transpulmonary driving pressure (ΔPL) - D4
Day 5
Transpulmonary driving pressure (ΔPL) - D5
Day 6
Transpulmonary driving pressure (ΔPL) - D6
Day 7
Transpulmonary driving pressure (ΔPL) - D7
Day 8
Transpulmonary driving pressure (ΔPL) - D8
Day 1
Tidal esophageal pressure swing (∆Pes) - D1
Day 2
Tidal esophageal pressure swing (∆Pes) - D2
Day 3
Tidal esophageal pressure swing (∆Pes) - D3
Day 4
Tidal esophageal pressure swing (∆Pes) - D4
Day 5
Tidal esophageal pressure swing (∆Pes) - D5
Day 6
Tidal esophageal pressure swing (∆Pes) - D6
Day 7
Tidal esophageal pressure swing (∆Pes) - D7
Day 8
Tidal esophageal pressure swing (∆Pes) - D8
Day 1
Occlusion pressure (∆Pocc) - D1
Day 2
Occlusion pressure (∆Pocc) - D2
Day 3
Occlusion pressure (∆Pocc) - D3
Day 4
Occlusion pressure (∆Pocc) - D4
Day 5
Occlusion pressure (∆Pocc) - D5
Day 6
Occlusion pressure (∆Pocc) - D6
Day 7
Occlusion pressure (∆Pocc) - D7
Day 8
Occlusion pressure (∆Pocc) - D8

Trial Safety

Trial Design

1 Treatment Group

Overall group
1 of 1
Experimental Treatment

150 Total Participants · 1 Treatment Group

Primary Treatment: Placement of nasogastric balloon · No Placebo Group · N/A

Overall group
Device
Experimental Group · 1 Intervention: Placement of nasogastric balloon · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months
Closest Location: The Hospital for Sick Children (SickKids) · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2017First Recorded Clinical Trial
1 TrialsResearching Respiratory Muscles
7 CompletedClinical Trials

Who is running the clinical trial?

Universitaire Ziekenhuizen KU LeuvenOTHER
608 Previous Clinical Trials
164,023 Total Patients Enrolled
University Hospital, AntwerpLead Sponsor
245 Previous Clinical Trials
103,381 Total Patients Enrolled
1 Trials studying Respiratory Muscles
12 Patients Enrolled for Respiratory Muscles
The Hospital for Sick ChildrenOTHER
635 Previous Clinical Trials
6,815,764 Total Patients Enrolled
University of TorontoOTHER
622 Previous Clinical Trials
719,230 Total Patients Enrolled
Universiteit AntwerpenOTHER
180 Previous Clinical Trials
230,534 Total Patients Enrolled
Research Foundation FlandersOTHER
60 Previous Clinical Trials
33,642 Total Patients Enrolled
1 Trials studying Respiratory Muscles
12 Patients Enrolled for Respiratory Muscles
KU LeuvenOTHER
482 Previous Clinical Trials
200,330,382 Total Patients Enrolled
Universitaire Ziekenhuizen LeuvenOTHER
849 Previous Clinical Trials
1,247,264 Total Patients Enrolled
Tom Schepens, M.D., Ph.D.Study DirectorPICU staff member

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The child is at least 28 days old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.