Clinical trial NCT05459116: Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
Official title: Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Muscles
Respiration, Artificial
Respiratory Function Tests
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: Universitaire Ziekenhuizen KU Leuven
name: The Hospital for Sick Children
name: University of Toronto
name: Universiteit Antwerpen
name: KU Leuven
First posted: 2022-07-14
Enrollment: 150
Sex: ALL
Minimum age (years): 29
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tidal esophageal pressure swing (∆Pes) - D1
timeFrame: ∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation
measure: Tidal esophageal pressure swing (∆Pes) - D2
timeFrame: ∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation
measure: Tidal esophageal pressure swing (∆Pes) - D3
timeFrame: ∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation
measure: Tidal esophageal pressure swing (∆Pes) - D4
timeFrame: ∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation
measure: Tidal esophageal pressure swing (∆Pes) - D5
timeFrame: ∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation
measure: Tidal esophageal pressure swing (∆Pes) - D6
timeFrame: ∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation
measure: Tidal esophageal pressure swing (∆Pes) - D7
timeFrame: ∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation
measure: Tidal esophageal pressure swing (∆Pes) - D8
timeFrame: ∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation
Secondary outcomes:
measure: Transpulmonary driving pressure (ΔPL) - D1
timeFrame: ∆PL (average over 1 minute recording) at day 1 of mechanical ventilation
measure: Transpulmonary driving pressure (ΔPL) - D2
timeFrame: ∆PL (average over 1 minute recording) at day 2 of mechanical ventilation
measure: Transpulmonary driving pressure (ΔPL) - D3
timeFrame: ∆PL (average over 1 minute recording) at day 3 of mechanical ventilation
measure: Transpulmonary driving pressure (ΔPL) - D4
timeFrame: ∆PL (average over 1 minute recording) at day 4 of mechanical ventilation
measure: Transpulmonary driving pressure (ΔPL) - D5
timeFrame: ∆PL (average over 1 minute recording) at day 5 of mechanical ventilation
measure: Transpulmonary driving pressure (ΔPL) - D6
timeFrame: ∆PL (average over 1 minute recording) at day 6 of mechanical ventilation
measure: Transpulmonary driving pressure (ΔPL) - D7
timeFrame: ∆PL (average over 1 minute recording) at day 7 of mechanical ventilation
measure: Transpulmonary driving pressure (ΔPL) - D8
timeFrame: ∆PL (average over 1 minute recording) at day 8 of mechanical ventilation
measure: Occlusion pressure (P0.1) - D1
timeFrame: P0.1 (average of 3 breaths) at day 1 of mechanical ventilation
measure: Occlusion pressure (P0.1) - D2
timeFrame: P0.1 (average of 3 breaths) at day 2 of mechanical ventilation
measure: Occlusion pressure (P0.1) - D3
timeFrame: P0.1 (average of 3 breaths) at day 3 of mechanical ventilation
measure: Occlusion pressure (P0.1) - D4
timeFrame: P0.1 (average of 3 breaths) at day 4 of mechanical ventilation
measure: Occlusion pressure (P0.1) - D5
timeFrame: P0.1 (average of 3 breaths) at day 5 of mechanical ventilation
measure: Occlusion pressure (P0.1) - D6
timeFrame: P0.1 (average of 3 breaths) at day 6 of mechanical ventilation
measure: Occlusion pressure (P0.1) - D7
timeFrame: P0.1 (average of 3 breaths) at day 7 of mechanical ventilation
measure: Occlusion pressure (P0.1) - D8
timeFrame: P0.1 (average of 3 breaths) at day 8 of mechanical ventilation
measure: End-expiratory diaphragm thickness (DTee) - D1
timeFrame: DTee (average of 3 breaths) at day 1 of mechanical ventilation
measure: End-expiratory diaphragm thickness (DTee) - D2
timeFrame: DTee (average of 3 breaths) at day 2 of mechanical ventilation
measure: End-expiratory diaphragm thickness (DTee) - D3
timeFrame: DTee (average of 3 breaths) at day 3 of mechanical ventilation
measure: End-expiratory diaphragm thickness (DTee) - D4
timeFrame: DTee (average of 3 breaths) at day 4 of mechanical ventilation
measure: End-expiratory diaphragm thickness (DTee) - D5
timeFrame: DTee (average of 3 breaths) at day 5 of mechanical ventilation
measure: End-expiratory diaphragm thickness (DTee) - D6
timeFrame: DTee (average of 3 breaths) at day 6 of mechanical ventilation
measure: End-expiratory diaphragm thickness (DTee) - D7
timeFrame: DTee (average of 3 breaths) at day 7 of mechanical ventilation
measure: End-expiratory diaphragm thickness (DTee) - D8
timeFrame: DTee (average of 3 breaths) at day 8 of mechanical ventilation
measure: Diaphragm thickening fraction (DTF) measured with ultrasound - D1
timeFrame: DTF (average of 3 breaths) at day 1 of mechanical ventilation
measure: Diaphragm thickening fraction (DTF) measured with ultrasound - D2
timeFrame: DTF (average of 3 breaths) at day 2 of mechanical ventilation
measure: Diaphragm thickening fraction (DTF) measured with ultrasound - D3
timeFrame: DTF (average of 3 breaths) at day 3 of mechanical ventilation
measure: Diaphragm thickening fraction (DTF) measured with ultrasound - D4
timeFrame: DTF (average of 3 breaths) at day 4 of mechanical ventilation
measure: Diaphragm thickening fraction (DTF) measured with ultrasound - D5
timeFrame: DTF (average of 3 breaths) at day 5 of mechanical ventilation
measure: Diaphragm thickening fraction (DTF) measured with ultrasound - D6
timeFrame: DTF (average of 3 breaths) at day 6 of mechanical ventilation
measure: Diaphragm thickening fraction (DTF) measured with ultrasound - D7
timeFrame: DTF (average of 3 breaths) at day 7 of mechanical ventilation
measure: Diaphragm thickening fraction (DTF) measured with ultrasound - D8
timeFrame: DTF (average of 3 breaths) at day 8 of mechanical ventilation
measure: Duration of mechanical ventilation
timeFrame: From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 4 months
measure: Maximal inspiratory pressure (MIP) - D1
timeFrame: MIP at day 1 of mechanical ventilation
measure: Maximal inspiratory pressure (MIP) - D2
timeFrame: MIP at day 2 of mechanical ventilation
measure: Maximal inspiratory pressure (MIP) - D3
timeFrame: MIP at day 3 of mechanical ventilation
measure: Maximal inspiratory pressure (MIP) - D4
timeFrame: MIP at day 4 of mechanical ventilation
measure: Maximal inspiratory pressure (MIP) - D5
timeFrame: MIP at day 5 of mechanical ventilation
measure: Maximal inspiratory pressure (MIP) - D6
timeFrame: MIP at day 6 of mechanical ventilation
measure: Maximal inspiratory pressure (MIP) - D7
timeFrame: MIP at day 7 of mechanical ventilation
measure: Maximal inspiratory pressure (MIP) - D8
timeFrame: MIP at day 8 of mechanical ventilation
measure: Need for tracheal reintubation after tracheal extubation
timeFrame: 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.
measure: Lung ultrasound scores (LUSS) - D1
timeFrame: LUSS at day 1 of mechanical ventilation
measure: Lung ultrasound scores (LUSS) - D2
timeFrame: LUSS at day 2 of mechanical ventilation
measure: Lung ultrasound scores (LUSS) - D3
timeFrame: LUSS at day 3 of mechanical ventilation
measure: Lung ultrasound scores (LUSS) - D4
timeFrame: LUSS at day 4 of mechanical ventilation
measure: Lung ultrasound scores (LUSS) - D5
timeFrame: LUSS at day 5 of mechanical ventilation
measure: Lung ultrasound scores (LUSS) - D6
timeFrame: LUSS at day 6 of mechanical ventilation
measure: Lung ultrasound scores (LUSS) - D7
timeFrame: LUSS at day 7 of mechanical ventilation
measure: Lung ultrasound scores (LUSS) - D8
timeFrame: LUSS at day 8 of mechanical ventilation
measure: ICU length of stay
timeFrame: 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
measure: ICU mortality
timeFrame: 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
measure: Hospital length of stay
timeFrame: 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
measure: Duration to decease
timeFrame: From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months
measure: Hospital mortality
timeFrame: 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
measure: Presence of clinical signs of muscle weakness at ICU discharge
timeFrame: 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
measure: Presence of clinical signs of muscle weakness at hospital discharge
timeFrame: 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
measure: ICU readmission rate within 48 hours
timeFrame: 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
measure: Inspiratory muscle pressure (Pmus) - D1
timeFrame: Pmus at day 1 of mechanical ventilation
measure: Inspiratory muscle pressure (Pmus) - D2
timeFrame: Pmus at day 2 of mechanical ventilation
measure: Inspiratory muscle pressure (Pmus) - D3
timeFrame: Pmus at day 3 of mechanical ventilation
measure: Inspiratory muscle pressure (Pmus) - D4
timeFrame: Pmus at day 4 of mechanical ventilation
measure: Inspiratory muscle pressure (Pmus) - D5
timeFrame: Pmus at day 5 of mechanical ventilation
measure: Inspiratory muscle pressure (Pmus) - D6
timeFrame: Pmus at day 6 of mechanical ventilation
measure: Inspiratory muscle pressure (Pmus) - D7
timeFrame: Pmus at day 7 of mechanical ventilation
measure: Inspiratory muscle pressure (Pmus) - D8
timeFrame: Pmus at day 8 of mechanical ventilation
measure: Occlusion pressure (∆Pocc) - D1
timeFrame: ∆Pocc at day 1 of mechanical ventilation
measure: Occlusion pressure (∆Pocc) - D2
timeFrame: ∆Pocc at day 2 of mechanical ventilation
measure: Occlusion pressure (∆Pocc) - D3
timeFrame: ∆Pocc at day 3 of mechanical ventilation
measure: Occlusion pressure (∆Pocc) - D4
timeFrame: ∆Pocc at day 4 of mechanical ventilation
measure: Occlusion pressure (∆Pocc) - D5
timeFrame: ∆Pocc at day 5 of mechanical ventilation
measure: Occlusion pressure (∆Pocc) - D6
timeFrame: ∆Pocc at day 6 of mechanical ventilation
measure: Occlusion pressure (∆Pocc) - D7
timeFrame: ∆Pocc at day 7 of mechanical ventilation
measure: Occlusion pressure (∆Pocc) - D8
timeFrame: ∆Pocc at day 8 of mechanical ventilation
measure: Esophageal pressure-time product (PTPes) - D1
timeFrame: PTPes at day 1 of mechanical ventilation
measure: Esophageal pressure-time product (PTPes) - D2
timeFrame: PTPes at day 2 of mechanical ventilation
measure: Esophageal pressure-time product (PTPes) - D3
timeFrame: PTPes at day 3 of mechanical ventilation
measure: Esophageal pressure-time product (PTPes) - D4
timeFrame: PTPes at day 4 of mechanical ventilation
measure: Esophageal pressure-time product (PTPes) - D5
timeFrame: PTPes at day 5 of mechanical ventilation
measure: Esophageal pressure-time product (PTPes) - D6
timeFrame: PTPes at day 6 of mechanical ventilation
measure: Esophageal pressure-time product (PTPes) - D7
timeFrame: PTPes at day 7 of mechanical ventilation
measure: Esophageal pressure-time product (PTPes) - D8
timeFrame: PTPes at day 8 of mechanical ventilation
measure: Dead space ventilation (VD) - D1
timeFrame: VD at day 1 of mechanical ventilation
measure: Dead space ventilation (VD) - D2
timeFrame: VD at day 2 of mechanical ventilation
measure: Dead space ventilation (VD) - D3
timeFrame: VD at day 3 of mechanical ventilation
measure: Dead space ventilation (VD) - D4
timeFrame: VD at day 4 of mechanical ventilation
measure: Dead space ventilation (VD) - D5
timeFrame: VD at day 5 of mechanical ventilation
measure: Dead space ventilation (VD) - D6
timeFrame: VD at day 6 of mechanical ventilation
measure: Dead space ventilation (VD) - D7
timeFrame: VD at day 7 of mechanical ventilation
measure: Dead space ventilation (VD) - D8
timeFrame: VD at day 8 of mechanical ventilation
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital (UZA)
state: Antwerp
city: Leuven
country: Belgium
facility: University Hospital Leuven (UZL)
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
affiliation: PICU staff member
name: Tom Schepens, M.D., Ph.D.
role: STUDY_DIRECTOR
References: