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Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04276844
Acronym
INDYD
Enrollment
157
Registered
2020-02-19
Start date
2020-03-04
Completion date
2021-01-20
Last updated
2026-04-08

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

Conditions

Surgery, Cardiac

Keywords

Diaphragmatic paralysis, Respiratory complications

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTUltrasonography using the two-dimensional (2D) mode

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

DIAGNOSTIC_TESTRespiratory Functional Explorations

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

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of persistent diaphragmatic dysfunctions after cardiac surgery8 daysDiaphragmatic excursion measured during sniff test (displacement, mm)

Secondary

MeasureTime frameDescription
Incidence of respiratory complicationsup to 2 monthsOccurrence of pneumonia, atelectasis requiring bronchial clearing by fibroscopy, reintubation, prolonged mechanical ventilation (\>24h) or prolonged non-invasive ventilation (\>48h)
Intensive Care Unit (ICU) length of stayup to 2 monthsDuration of ICU stay measured in days
Hospital length of stayup to 2 monthsDuration of hospitalization measured in days
Respiratory function test in the group with persistent diaphragmatic dysfunction8 daysForced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7 and compared to day 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026