Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

Surgery, Cardiac Clinical Trial

— INDYD  

Official title:

Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276844
• Other study ID #: 2019/06
• Status: Completed
• Start date: March 4, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: January 2021
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 20, 2021
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery, Cardiac

Intervention

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

Locations

Country	Name	City	State
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of persistent diaphragmatic dysfunctions after cardiac surgery	Diaphragmatic excursion measured during sniff test (displacement, mm)	8 days
Secondary	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
Secondary	Intensive Care Unit (ICU) length of stay	Duration of ICU stay measured in days	up to 2 months
Secondary	Hospital length of stay	Duration of hospitalization measured in days	up to 2 months
Secondary	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