Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Ventilation (NIV) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT05953298 | Completed

• 1 other identifier: CHUBX 2023/10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this physiologic research is to assess lung volumes variations under NIV in stable COPD patients to understand the impact of "high-intensity" ventilation following the current recommendations. The main objective is to evaluate the variation of End-expiratory lung volume (EELV) reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography during a 20 minutes NIV session.

Conditions

COPD

Keywords

Chronic obstructive pulmonary disease; non invasive ventilation; end-expiratory lung volume; electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• End-Expiratory Lung Impedance (EELI) evolution during NIV sessions

  End-Expiratory Lung impedance is related to the End-Expiratory Lung Volume reflecting the functional residual capacity (FRC). It is obtained by electrical impedance tomography. EELI values are presented in arbitrary values (v.a) and can vary greatly between individuals. Thus, as previously proposed by (4), the EELI values during the different measurement phases will be assessed and presented as a percentage change from their reference value. The main objective of this study aims to observe the evolution of the EELI under NIV in stable COPD patients, the reference EELI value will be that measured at T1 (NIV initiation+1 minute), compared to that measured at T2 (NIV+20minutes) under the ∆EELI%T2 abbreviation from the following calculation: ∆EELI%T2 = (EELIT1-EELIT2)/EELIT1\*100

  Day 1

Secondary Outcomes (2)

• End-Expiratory Lung Impedance (EELI) evolution before, during and NIV sessions

  Day 1

• Transcutaneous capnia

  Day 1

Study Arms (1)

Patients with COPD

EXPERIMENTAL

Patients with COPD in stable condition fitted with long-term NIV

Device: Electrical impedance tomography (EIT)

Interventions

Electrical impedance tomography (EIT) DEVICE

Electrical impedance tomography (EIT) is a non-invasive evaluation tool, without radiation, simple to set up at the patient's bedside and validated, making it possible to monitor the distribution of ventilation and lung recruitment with high temporal resolution, dynamic way and at a regional level

Patients with COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with COPD in stable condition fitted with long-term NIV followed at Bordeaux University Hospital;
• Patient benefiting from social protection from the national health insurance fund;
• Patient having read the patient information letter and given his non-objection to participate in the study.

You may not qualify if:

• Obesity with a BMI \> 35;
• Respiratory exacerbation during treatment;
• Patient with one or more contraindications to the implementation of EIT(7):
• Pacemaker, defibrillator, electric active medical device;
• Damaged skin condition, dressing on the observation area;
• Risk related to fitting the belt (fracture, spinal lesions, etc.);
• Uncontrollable movements;
• Current electrotherapy;
• Presence of a magnetic field (magnetic resonance imaging);
• Other bioimpedance measurements in progress;
• Pregnant woman ;
• Tidal volume \< 1ml/kg;
• Patient having read the patient information letter and refusing to participate in the study (Loi Jardé research category 3);
• Patient under guardianship, curatorship, or deprived of freedom of administrative or judicial decision;
• Patient included in other protocols that may interact with this study;

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Haut Lévêque, Centre Hospitalier Universitaire de Bordeaux

Pessac, 33600, France

Location

Related Publications (4)

• Schwarz SB, Magnet FS, Windisch W. Why High-Intensity NPPV is Favourable to Low-Intensity NPPV: Clinical and Physiological Reasons. COPD. 2017 Aug;14(4):389-395. doi: 10.1080/15412555.2017.1318843. Epub 2017 May 11.

  PMID: 28494170 BACKGROUND

• Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.

  PMID: 27596161 BACKGROUND

• Hinz J, Hahn G, Neumann P, Sydow M, Mohrenweiser P, Hellige G, Burchardi H. End-expiratory lung impedance change enables bedside monitoring of end-expiratory lung volume change. Intensive Care Med. 2003 Jan;29(1):37-43. doi: 10.1007/s00134-002-1555-4. Epub 2002 Nov 20.

  PMID: 12528020 BACKGROUND

• Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.

  PMID: 27997805 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leo GRASSION, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 20, 2023
• Study Start: June 26, 2023
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)