Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Tidal esophageal pressure swing (∆Pes) - D1
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 29 Days to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age > 28 days
- •weight > 3kg
- •requiring invasive mechanical ventilation
- •anticipated length of ventilation > 48h
Exclusion Criteria
- •refusal of consent
- •mechanical ventilation ≤ 2 weeks before inclusion
- •known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
- •contra-indication to the placement of a naso-gastric esophageal balloon catheter
Arms & Interventions
Overall group
Placement of a nasogastric balloon
Intervention: Placement of nasogastric balloon (Device)
Outcomes
Primary Outcomes
Tidal esophageal pressure swing (∆Pes) - D1
Time Frame: ∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D7
Time Frame: ∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D2
Time Frame: ∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D3
Time Frame: ∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D4
Time Frame: ∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D8
Time Frame: ∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D5
Time Frame: ∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D6
Time Frame: ∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Secondary Outcomes
- Presence of clinical signs of muscle weakness at hospital discharge(From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months)
- Inspiratory muscle pressure (Pmus) - D2(Pmus at day 2 of mechanical ventilation)
- Inspiratory muscle pressure (Pmus) - D8(Pmus at day 8 of mechanical ventilation)
- Occlusion pressure (∆Pocc) - D2(∆Pocc at day 2 of mechanical ventilation)
- Transpulmonary driving pressure (ΔPL) - D1(∆PL (average over 1 minute recording) at day 1 of mechanical ventilation)
- Inspiratory muscle pressure (Pmus) - D3(Pmus at day 3 of mechanical ventilation)
- Inspiratory muscle pressure (Pmus) - D5(Pmus at day 5 of mechanical ventilation)
- Inspiratory muscle pressure (Pmus) - D4(Pmus at day 4 of mechanical ventilation)
- Transpulmonary driving pressure (ΔPL) - D4(∆PL (average over 1 minute recording) at day 4 of mechanical ventilation)
- Transpulmonary driving pressure (ΔPL) - D7(∆PL (average over 1 minute recording) at day 7 of mechanical ventilation)
- Transpulmonary driving pressure (ΔPL) - D8(∆PL (average over 1 minute recording) at day 8 of mechanical ventilation)
- End-expiratory diaphragm thickness (DTee) - D1(DTee (average of 3 breaths) at day 1 of mechanical ventilation)
- Transpulmonary driving pressure (ΔPL) - D2(∆PL (average over 1 minute recording) at day 2 of mechanical ventilation)
- Transpulmonary driving pressure (ΔPL) - D3(∆PL (average over 1 minute recording) at day 3 of mechanical ventilation)
- Transpulmonary driving pressure (ΔPL) - D6(∆PL (average over 1 minute recording) at day 6 of mechanical ventilation)
- Occlusion pressure (P0.1) - D1(P0.1 (average of 3 breaths) at day 1 of mechanical ventilation)
- Occlusion pressure (P0.1) - D2(P0.1 (average of 3 breaths) at day 2 of mechanical ventilation)
- Occlusion pressure (P0.1) - D5(P0.1 (average of 3 breaths) at day 5 of mechanical ventilation)
- End-expiratory diaphragm thickness (DTee) - D5(DTee (average of 3 breaths) at day 5 of mechanical ventilation)
- End-expiratory diaphragm thickness (DTee) - D8(DTee (average of 3 breaths) at day 8 of mechanical ventilation)
- Diaphragm thickening fraction (DTF) measured with ultrasound - D5(DTF (average of 3 breaths) at day 5 of mechanical ventilation)
- Occlusion pressure (P0.1) - D6(P0.1 (average of 3 breaths) at day 6 of mechanical ventilation)
- Diaphragm thickening fraction (DTF) measured with ultrasound - D3(DTF (average of 3 breaths) at day 3 of mechanical ventilation)
- Maximal inspiratory pressure (MIP) - D5(MIP at day 5 of mechanical ventilation)
- Maximal inspiratory pressure (MIP) - D6(MIP at day 6 of mechanical ventilation)
- Need for tracheal reintubation after tracheal extubation(From date of inclusion until the date of reintubation or date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months.)
- Lung ultrasound scores (LUSS) - D1(LUSS at day 1 of mechanical ventilation)
- Transpulmonary driving pressure (ΔPL) - D5(∆PL (average over 1 minute recording) at day 5 of mechanical ventilation)
- Occlusion pressure (P0.1) - D4(P0.1 (average of 3 breaths) at day 4 of mechanical ventilation)
- End-expiratory diaphragm thickness (DTee) - D2(DTee (average of 3 breaths) at day 2 of mechanical ventilation)
- End-expiratory diaphragm thickness (DTee) - D4(DTee (average of 3 breaths) at day 4 of mechanical ventilation)
- Diaphragm thickening fraction (DTF) measured with ultrasound - D1(DTF (average of 3 breaths) at day 1 of mechanical ventilation)
- Diaphragm thickening fraction (DTF) measured with ultrasound - D8(DTF (average of 3 breaths) at day 8 of mechanical ventilation)
- Maximal inspiratory pressure (MIP) - D1(MIP at day 1 of mechanical ventilation)
- Lung ultrasound scores (LUSS) - D2(LUSS at day 2 of mechanical ventilation)
- Lung ultrasound scores (LUSS) - D5(LUSS at day 5 of mechanical ventilation)
- Lung ultrasound scores (LUSS) - D8(LUSS at day 8 of mechanical ventilation)
- Duration to decease(From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months)
- Occlusion pressure (P0.1) - D3(P0.1 (average of 3 breaths) at day 3 of mechanical ventilation)
- Occlusion pressure (P0.1) - D7(P0.1 (average of 3 breaths) at day 7 of mechanical ventilation)
- Occlusion pressure (P0.1) - D8(P0.1 (average of 3 breaths) at day 8 of mechanical ventilation)
- End-expiratory diaphragm thickness (DTee) - D3(DTee (average of 3 breaths) at day 3 of mechanical ventilation)
- End-expiratory diaphragm thickness (DTee) - D6(DTee (average of 3 breaths) at day 6 of mechanical ventilation)
- End-expiratory diaphragm thickness (DTee) - D7(DTee (average of 3 breaths) at day 7 of mechanical ventilation)
- Maximal inspiratory pressure (MIP) - D4(MIP at day 4 of mechanical ventilation)
- Maximal inspiratory pressure (MIP) - D8(MIP at day 8 of mechanical ventilation)
- Lung ultrasound scores (LUSS) - D6(LUSS at day 6 of mechanical ventilation)
- Lung ultrasound scores (LUSS) - D7(LUSS at day 7 of mechanical ventilation)
- ICU mortality(From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months)
- Hospital length of stay(From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months)
- Presence of clinical signs of muscle weakness at ICU discharge(From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months)
- Inspiratory muscle pressure (Pmus) - D1(Pmus at day 1 of mechanical ventilation)
- Diaphragm thickening fraction (DTF) measured with ultrasound - D2(DTF (average of 3 breaths) at day 2 of mechanical ventilation)
- Diaphragm thickening fraction (DTF) measured with ultrasound - D4(DTF (average of 3 breaths) at day 4 of mechanical ventilation)
- Diaphragm thickening fraction (DTF) measured with ultrasound - D6(DTF (average of 3 breaths) at day 6 of mechanical ventilation)
- Maximal inspiratory pressure (MIP) - D2(MIP at day 2 of mechanical ventilation)
- Maximal inspiratory pressure (MIP) - D3(MIP at day 3 of mechanical ventilation)
- Lung ultrasound scores (LUSS) - D3(LUSS at day 3 of mechanical ventilation)
- ICU length of stay(From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months)
- ICU readmission rate within 48 hours(From date of ICU discharge until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months)
- Diaphragm thickening fraction (DTF) measured with ultrasound - D7(DTF (average of 3 breaths) at day 7 of mechanical ventilation)
- Duration of mechanical ventilation(From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 4 months)
- Maximal inspiratory pressure (MIP) - D7(MIP at day 7 of mechanical ventilation)
- Lung ultrasound scores (LUSS) - D4(LUSS at day 4 of mechanical ventilation)
- Hospital mortality(From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months)
- Occlusion pressure (∆Pocc) - D1(∆Pocc at day 1 of mechanical ventilation)
- Occlusion pressure (∆Pocc) - D3(∆Pocc at day 3 of mechanical ventilation)
- Occlusion pressure (∆Pocc) - D5(∆Pocc at day 5 of mechanical ventilation)
- Occlusion pressure (∆Pocc) - D6(∆Pocc at day 6 of mechanical ventilation)
- Esophageal pressure-time product (PTPes) - D4(PTPes at day 4 of mechanical ventilation)
- Dead space ventilation (VD) - D3(VD at day 3 of mechanical ventilation)
- Dead space ventilation (VD) - D6(VD at day 6 of mechanical ventilation)
- Inspiratory muscle pressure (Pmus) - D6(Pmus at day 6 of mechanical ventilation)
- Occlusion pressure (∆Pocc) - D7(∆Pocc at day 7 of mechanical ventilation)
- Occlusion pressure (∆Pocc) - D8(∆Pocc at day 8 of mechanical ventilation)
- Esophageal pressure-time product (PTPes) - D3(PTPes at day 3 of mechanical ventilation)
- Inspiratory muscle pressure (Pmus) - D7(Pmus at day 7 of mechanical ventilation)
- Occlusion pressure (∆Pocc) - D4(∆Pocc at day 4 of mechanical ventilation)
- Esophageal pressure-time product (PTPes) - D5(PTPes at day 5 of mechanical ventilation)
- Dead space ventilation (VD) - D1(VD at day 1 of mechanical ventilation)
- Dead space ventilation (VD) - D8(VD at day 8 of mechanical ventilation)
- Esophageal pressure-time product (PTPes) - D2(PTPes at day 2 of mechanical ventilation)
- Esophageal pressure-time product (PTPes) - D7(PTPes at day 7 of mechanical ventilation)
- Dead space ventilation (VD) - D4(VD at day 4 of mechanical ventilation)
- Esophageal pressure-time product (PTPes) - D1(PTPes at day 1 of mechanical ventilation)
- Esophageal pressure-time product (PTPes) - D6(PTPes at day 6 of mechanical ventilation)
- Esophageal pressure-time product (PTPes) - D8(PTPes at day 8 of mechanical ventilation)
- Dead space ventilation (VD) - D2(VD at day 2 of mechanical ventilation)
- Dead space ventilation (VD) - D5(VD at day 5 of mechanical ventilation)
- Dead space ventilation (VD) - D7(VD at day 7 of mechanical ventilation)