Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

NCT04276844 | Completed

• 1 other identifier: 2019/06
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery, Cardiac

Keywords

Diaphragmatic paralysis; Respiratory complications

Outcome Measures

Primary Outcomes (1)

• Incidence of persistent diaphragmatic dysfunctions after cardiac surgery

  Diaphragmatic excursion measured during sniff test (displacement, mm)

  8 days

Secondary Outcomes (4)

• Incidence of respiratory complications

  up to 2 months

• Intensive Care Unit (ICU) length of stay

  up to 2 months

• Hospital length of stay

  up to 2 months

• Respiratory function test in the group with persistent diaphragmatic dysfunction

  8 days

Study Arms (2)

Non diaphragmatic dysfunction at day 7 post-surgery

Diaphragmatic displacement after sniff test ≥ 16 mm for women and ≥ 18 mm for men

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

Persistent diaphragmatic dysfunction at day 7 post-surgery

Diaphragmatic displacement after sniff test \< 16 mm for women and \< 18 mm for men

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

Interventions

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.

Non diaphragmatic dysfunction at day 7 post-surgery; Persistent diaphragmatic dysfunction at day 7 post-surgery

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

Persistent diaphragmatic dysfunction at day 7 post-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

150 patients undergoing cardiac surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré

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

Location

Related Publications (1)

• Laghlam D, Naudin C, Srour A, Monsonego R, Malvy J, Rahoual G, Squara P, Nguyen LS, Estagnasie P. Persistent diaphragm dysfunction after cardiac surgery is associated with adverse respiratory outcomes: a prospective observational ultrasound study. Can J Anaesth. 2023 Feb;70(2):228-236. doi: 10.1007/s12630-022-02360-8. Epub 2022 Dec 13.

  PMID: 36513852 RESULT

MeSH Terms

Conditions

Respiratory Paralysis

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: March 4, 2020
• Primary Completion: November 3, 2020
• Study Completion: January 20, 2021
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)