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NCT Number: NCT06420999

Incidence and Impact of ICU-acquired Diaphragm Weakness

ICU survivors are at an increased risk of hospital and ICU readmission. Among the complications of ICU stay, diaphragmatic dysfunction is common, with a prevalence of 60 to 80%, and is associated with increased mortality and prolonged hospital stays. Furthermore, several studies have reported that the observation of impaired respiratory muscle function upon ICU discharge is associated with a poor long-term prognosis. However, the incidence and prognostic impact of persistent diaphragmatic dysfunction at ICU discharge have never been evaluated. The measurement of dyspnea, a composite evaluation of respiratory muscle function, has not been assessed for predicting prognosis upon ICU discharge.

The hypothesis of the project is that the presence of ICU-acquired diaphragmatic dysfunction at ICU discharge is associated with a poorer prognosis within 90 days.

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Key information

Conditions

Diaphragm Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Médecine intensive Réanimation

Paris, 75013, France

Location status: Recruiting

Location contact

Martin DRES, MD, PhD

CONTACT

[email protected]

0142167809

About this study

Diaphragmatic function of patients will be assessed by ultrasound within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.

ICU discharge will be defined a priori using a checklist. Diaphragmatic activity will be assessed by bedside diaphragmatic ultrasound. Patients will be positioned in a semi-sitting position (trunk inclination between 30 and 45°) to allow for better visualization of the right hemidiaphragm. The diaphragmatic assessment will include the measurement of inspiratory and expiratory thickness to calculate the diaphragmatic thickening fraction (intercostal approach) and the measurement of diaphragmatic excursion (subcostal approach) during the respiratory cycle. These measurements will be taken at rest. Diaphragmatic dysfunction will be defined by a thickening fraction strictly less than 20% and/or a diaphragmatic excursion strictly less than 1 cm at rest.

Dyspnea will be assessed using a visual analog scale (VAS) ranging from 0 (no dyspnea) to 10 (maximum dyspnea). It will be evaluated within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Invasive or non-invasive respiratory support (ventilation, high-flow oxygen therapy, whatever the reason) for at least 48 hours.
  • Weaning from respiratory support (invasive or not) within the last 24 hours.
  • Patient (or trusted person/relative) informed and not opposed to the study.

Exclusion criteria

  • Known pre-existing diaphragmatic dysfunction (phrenic lesion, neuromuscular disease, etc.)
  • Patients with tracheostomy
  • Non-communicating patients
  • Patients deprived of liberty by court or administrative order, or under legal protection (guardianship, curators).

Treatment and study plan

Diaphragmatic ultrasound and data collection

Other

At the inclusion visit, anamnestic data available in the medical record and clinical data (vitals, chest X-ray) will be collected. At the same time, a diaphragmatic ultrasound will be performed in the half-seated position to measure diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm at rest. A follow-up visit will be made on the day of discharge from intensive care, during which diaphragmatic ultrasound will be performed At D90 (+/- 15 days), the following information will be collected by consulting the electronic medical record, or by telephone if the information is not available in the record: date of discharge from hospital, date of death, date and reason for readmission to hospital or intensive care, possible introduction of long-term non-invasive ventilation, new respiratory complication after discharge from intensive care (pneumonia, atelectasis).

Primary outcomes

  1. Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90

    Time frame: 90 days after inclusion (+/- 15 days)

    Mortality

Secondary outcomes

  1. Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality).

    Time frame: The day of discharge from ICU

    Measurement of dyspnea on day of discharge from intensive care, assessed by visual analog scale (VAS). Scale of 1 to 10 with 10 corresponding to minimal comfort

  2. Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care.

    Time frame: The day of discharge from ICU

    Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction<20%.

  3. Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care.

    Time frame: The day of discharge from ICU

    Clinically significant dyspnea defined by a VAS>3/10. Scale of 1 to 10 with 10 corresponding to minimal comfort

  4. Association between the presence of diaphragmatic dysfunction on the day of discharge from intensive care and length of hospital stay.

    Time frame: 90 days after inclusion (+/- 15 days)

    Length of hospital stay

  5. Association between the presence of diaphragmatic dysfunction within 24 hours of weaning from ventilation and length of hospital stay.

    Time frame: On the day ventilation is weaned

    Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction<20%.

  6. Association between diaphragmatic dysfunction and the risk of hospital and intensive care readmissions

    Time frame: 90 days after inclusion (+/- 15 days)

    Percentage of readmissions to intensive care and hospital at D90.

  7. Association between diaphragmatic dysfunction and the risk of respiratory complications at D90.

    Time frame: 90 days after inclusion (+/- 15 days)

    The percentage of respiratory complications at D90, defined by the occurrence of pneumonia, reintubation, atelectasis (or worsening in case of pre-existing abnormality).

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Dres, MD,PHD

CONTACT

[email protected]

0142167809

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PRODIGY

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 20, 2024
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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