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Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery (INDYD)

C

CMC Ambroise Paré

Status

Completed

Conditions

Surgery, Cardiac

Treatments

Diagnostic Test: Ultrasonography using the two-dimensional (2D) mode
Diagnostic Test: Respiratory Functional Explorations

Study type

Observational

Funder types

Other

Identifiers

NCT04276844
2019/06

Details and patient eligibility

About

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.

Full 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.

Enrollment

157 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

157 participants in 2 patient groups

Non diaphragmatic dysfunction at day 7 post-surgery
Description:
Diaphragmatic displacement after sniff test ≥ 16 mm for women and ≥ 18 mm for men
Treatment:
Diagnostic Test: Ultrasonography using the two-dimensional (2D) mode
Persistent diaphragmatic dysfunction at day 7 post-surgery
Description:
Diaphragmatic displacement after sniff test \< 16 mm for women and \< 18 mm for men
Treatment:
Diagnostic Test: Respiratory Functional Explorations
Diagnostic Test: Ultrasonography using the two-dimensional (2D) mode

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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