Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

Completed

• Conditions: Surgery, Cardiac
• Interventions: Diagnostic Test: Ultrasonography using the two-dimensional (2D) mode; Diagnostic Test: Respiratory Functional Explorations

• Registration Number: NCT04276844
• Lead Sponsor: CMC Ambroise Paré

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.

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-19
• Study Start: 2020-03-04
• Primary Completion: 2020-11-03
• Status Verified: 2021-01
• Study Completion: 2021-01-20
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of persistent diaphragmatic dysfunctions after cardiac surgery	8 days	Diaphragmatic excursion measured during sniff test (displacement, mm)

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	up to 2 months	Duration of hospitalization measured in days
Incidence of respiratory complications	up to 2 months	Occurrence of pneumonia, atelectasis requiring bronchial clearing by fibroscopy, reintubation, prolonged mechanical ventilation (\>24h) or prolonged non-invasive ventilation (\>48h)
Respiratory function test in the group with persistent diaphragmatic dysfunction	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
Intensive Care Unit (ICU) length of stay	up to 2 months	Duration of ICU stay measured in days

Trial Locations

Locations (1)

CMC Ambroise Paré; 🇫🇷 Neuilly-sur-Seine, Ile-de-France, France