ICU-Acquired Respiratory muscle Dysfunction (the ICARD study)

ICU-Acquired Respiratory muscle Dysfunction (the ICARD study) - ICARD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51396

Enrollment

110

Registered

2022-08-17

Start date

2024-07-08

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm muscle weakness Expiratory muscle weakness Ventilator induced expiratory muscle dysfunction Ventilator-induced diaphragm dysfunction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. mechanically ventilated patients planned for a laparotomy for suspected or proven intra-abdominal sepsis or for other reasons such as trauma, abdominal haemorrhage, vascular surgery. (50 patients) 2. Patients scheduled for elective thoracotomy or lobectomy for removal of a pulmonary tumor (30 patients). 3. Patients scheduled for elective abdominal surgery (30 patients) -Age: >18 years -Informed consent

Exclusion criteria

Exclusion criteria: COPD (GOLD 3-4) or CHF (NYHA 3-4) -Neuromuscular disease -Chronic metabolic disease -Pulmonary hypertension -Chronic use of corticosteroids (defined as >7.5 mg/day for at least 3 months) -Drugs known to alter muscle structure and function ->10% weight loss within last 6 months

Design outcomes

Primary

Measure	Time frame
Contractile force of single respiratory muscle fibers.	—

Secondary

Measure	Time frame
Morphological determination of muscle fiber cross sectional area Muscle fiber ultrastructure by electronmicrocopy Muscle fiber nuclear shape and function Posttranslational modification of contractile proteins Diaphragm cytokine profile Plasma cytokine profile Gene expression analysis by RNA-sequencing Comparison of findings from diaphragm muscle to those from the non-respiratory rectus abdominus muscle (and latissimus dorsi in the control group). Comparison of findings from diaphragm and rectus abdominus muscle (latissimus dorsi in the control group) to expiratory respiratory muscles (lateral abdominal muscles in the ICU group and in control group). Effect of duration of mechanical ventilation on contractile strength (by comparing individuals with various durations of mechanical ventilation) Microvascular function Inflammation Diaphragm and expiratory muscle thickness, echogenicity and layering determined by bedside ultrasound.	—

Measure

Time frame

Morphological determination of muscle fiber cross sectional area Muscle fiber ultrastructure by electronmicrocopy Muscle fiber nuclear shape and function Posttranslational modification of contractile proteins Diaphragm cytokine profile Plasma cytokine profile Gene expression analysis by RNA-sequencing Comparison of findings from diaphragm muscle to those from the non-respiratory rectus abdominus muscle (and latissimus dorsi in the control group). Comparison of findings from diaphragm and rectus abdominus muscle (latissimus dorsi in the control group) to expiratory respiratory muscles (lateral abdominal muscles in the ICU group and in control group). Effect of duration of mechanical ventilation on contractile strength (by comparing individuals with various durations of mechanical ventilation) Microvascular function Inflammation Diaphragm and expiratory muscle thickness, echogenicity and layering determined by bedside ultrasound.

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Countries

Netherlands

Outcome results