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

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.

Study Overview

• Status: Completed
• Conditions: Surgery, Cardiac
• Intervention / Treatment: Diagnostic test: Ultrasonography using the two-dimensional (2D) mode; Diagnostic test: Respiratory Functional Explorations

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 Type: Observational
• Enrollment (Actual): 157

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Neuilly-sur-Seine, Ile-de-France, France, 92200
      • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

150 patients undergoing cardiac surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Diaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
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; 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 test: Respiratory Functional Explorations; Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of persistent diaphragmatic dysfunctions after cardiac surgery	Diaphragmatic excursion measured during sniff test (displacement, mm)	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of respiratory complications	Occurrence of pneumonia, atelectasis requiring bronchial clearing by fibroscopy, reintubation, prolonged mechanical ventilation (>24h) or prolonged non-invasive ventilation (>48h)	up to 2 months
Intensive Care Unit (ICU) length of stay	Duration of ICU stay measured in days	up to 2 months
Hospital length of stay	Duration of hospitalization measured in days	up to 2 months
Respiratory function test in the group with persistent diaphragmatic dysfunction	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	8 days

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Actual): November 3, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Diaphragmatic paralysis; Respiratory complications
• Other Study ID Numbers: 2019/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No