Influence of Respiratory Mechanics on Diaphragmatic Dysfunction in COPD Patients Who Have Failed NIV (RHYDIAN) (RHYDIAN)

Influence of Respiratory Mechanics on Diaphragmatic Dysfunction in COPD Patients Who Have Failed Non-invasive Mechanical Ventilation

Although non-invasive mechanical ventilation (NIV) is the gold standard treatment for patients with acute exacerbation of COPD (AECOPD) who develop respiratory acidosis, failure rate are still high ranging from 5% to 40%. Recent studies have shown that the onset of severe diaphragmatic dysfunction (DD) during AECOPD increases risk of NIV failure and mortality in this subset of patients. Although the imbalance between the load and the contractile capacity of inspiratory muscles seems the main cause of AECOPD-induced hypercapnic respiratory failure, data regarding the influence of mechanical derangement on diaphragmatic performance in this acute phase are lacking. With this study we aim at investigating the impact of respiratory mechanics on diaphragm function in AECOPD patients who experienced NIV failure. AECOPD with respiratory acidosis admitted to the ICU of the University Hospital of Modena from 2017-2018 undergoing mechanical ventilation (MV) due to NIV failure were enrolled. The study protocol consisted of two consecutive phases; in the first step measurements of static respiratory mechanics and end expiratory lung volume (EELV) were performed after 30 minutes of MV in volume control mode. In the second step transdiaphragmatic pressure (Pdi) was calculated by means of a sniff maneuver (Maximal Pdi) after 30 minutes of spontaneous breathing trial. Linear regression analysis and Pearson's correlation coefficient was used to asses the association between Maximal Pdi values and static and dynamic mechanical features and the association between Maximal Pdi and Pdi/Maximal Pdi.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation; Mechanical Ventilation; Diaphragm Dysfunction
• Intervention / Treatment: Other: Respiratory mechanics assessment

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy
    • University Hospital of Modena Policlinico di Modena

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: Non-Probability Sample

Study Population

Cohort study

Description

Inclusion Criteria:

• age over 18 years
• AECOPD with respiratory acidosis admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena (Italy) undergoing endotracheal intubation due to NIV failure.

Exclusion Criteria:

• history of neuromuscular disease,
• presence of chest wall deformities,
• coexistence of interstitial lung disease,
• presence of pulmonary edema,
• severe hemodynamic instability,
• septic shock,
• evidence of lobar pneumonia or bilateral parenchymal consolidation at chest X-ray on admission,
• contraindication to NIV,
• previously assessed diaphragmatic palsy,
• intracranial hypertension,
• known pregnancy,
• need for immediate endotracheal intubation,
• neurologic impairment,
• lack of collaboration,
• unreliable maneuver to calculate maximal transdiaphragmatic pressure.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of static elastance on diaphragm function in AECOPD patient who failed NIV	Correlation between static elastance and Maximal Pdi in patients undergoing mechanical ventilation for AECOPD	30 days from Respiratory Intensive Care Unit admission
Impact of dynamic intrinsic Positive End Expiratory Pressure on diaphragm function in AECOPD patient who failed NIV	Correlation between dynamic intrinsic Positive End Expiratory Pressure and Maximal Pdi in patients undergoing mechanical ventilation for AECOPD	30 days from Respiratory Intensive Care Unit admission

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UModenaReggio 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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