Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

NCT ID: NCT04276844

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-04

Study Completion Date

2021-01-20

Brief Summary

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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

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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.

Conditions

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Surgery, Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non diaphragmatic dysfunction at day 7 post-surgery

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

Ultrasonography using the two-dimensional (2D) mode

Intervention Type 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.

Persistent diaphragmatic dysfunction at day 7 post-surgery

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

Ultrasonography using the two-dimensional (2D) mode

Intervention Type 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.

Respiratory Functional Explorations

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CMC Ambroise Paré

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

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 36513852 (View on PubMed)

Other Identifiers

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2019/06

Identifier Type: -

Identifier Source: org_study_id

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