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NCT Number: NCT04276844

Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

Postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction (DD) is one of the main risk factors for post-operative respiratory distress syndrome. It alters the ventilatory mechanical function of patients and promotes pneumonia. In the literature, risk factors included older age, diabetes, harvesting of a mammary artery, intraoperative ice solution using, prolonged cardiopulmonary bypass and intra-operative phrenic nerve injury.

Ultrasonography using the two-dimensional (2D) mode is a diagnosis tool for DD. For patients with DD, ultrasound criteria are: 1) an excursion during quiet breathing < 9 mm for woman and < 10 mm for man, 2) an excursion after sniff test < 16 mm for woman and < 18 mm for man and 3) an excursion during deep breathing < 37 mm for woman and < 47 mm for man. A paradoxical diaphragmatic ascent may also be observed during inspiration.

DD may be transient, linked to mechanical factors such as pain, the presence of pleural and mediastinal drains, lying down or sternotomy; with recovery from 5 postoperative days. It may be more prolonged (persistent after 7 days) in connection with a partial or complete phrenic nerve injury and / or diaphragmatic devascularization after mammary artery harvesting.

The aim of this prospective study is to determine the incidence of persistent DD after cardiac surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

About this study

Diaphragmatic amplitude will be assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.

Patients with persistent DD at day 7 post-surgery will have additional Respiratory Functional Explorations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing cardiac surgery requiring sternotomy
  • Consent for participation
  • Affiliation to the social security system

Exclusion criteria

  • Contraindication to preoperative respiratory functional explorations
  • Pregnant or breastfeeding women
  • Patients under protection of the adults (guardianship, curators or safeguard of justice)
  • Communication difficulties or neuropsychiatric disorder

Treatment and study plan

Ultrasonography using the two-dimensional (2D) mode

Diagnostic Test

Diaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.

Respiratory Functional Explorations

Diagnostic Test

Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7

Primary outcomes

  1. Incidence of persistent diaphragmatic dysfunctions after cardiac surgery

    Time frame: 8 days

    Diaphragmatic excursion measured during sniff test (displacement, mm)

Secondary outcomes

  1. Incidence of respiratory complications

    Time frame: up to 2 months

    Occurrence of pneumonia, atelectasis requiring bronchial clearing by fibroscopy, reintubation, prolonged mechanical ventilation (>24h) or prolonged non-invasive ventilation (>48h)

  2. Intensive Care Unit (ICU) length of stay

    Time frame: up to 2 months

    Duration of ICU stay measured in days

  3. Hospital length of stay

    Time frame: up to 2 months

    Duration of hospitalization measured in days

  4. Respiratory function test in the group with persistent diaphragmatic dysfunction

    Time frame: 8 days

    Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7 and compared to day 0

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Acronym: INDYD

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 19, 2020
Registry last updated
Apr 8, 2026

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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