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

Mechanical Ventilation Clinical Trial

— RHYDIAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852394
• Other study ID #: UModenaReggio 4
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation
• Diaphragm Dysfunction
• Mechanical Ventilation

Intervention

Other:
• Respiratory mechanics assessment
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.

Locations

Country	Name	City	State
Italy	University Hospital of Modena Policlinico di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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