Clinical trial NCT05953298: Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Ventilation (NIV) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Evaluation by Electrical Impedancemetry of the Variation of Lung Volumes Under NIV in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Chronic obstructive pulmonary disease
non invasive ventilation
end-expiratory lung volume
electrical impedance tomography
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: In patients with COPD, European recommendations recommend the use of NIV with a "high pressure" setting (1). These ventilatory modalities go against what is done in acute. Indeed, in this case, the pressures are much lower, because the risk of asynchronies and dynamic hyperinflation under NIV is then very important.

The usual techniques for evaluating lung volume and dynamic hyperinflation do not allow this to be measured under NIV.

Assessing lung volumes under NIV in stable COPD patients is therefore of major interest in understanding the impact of "high-intensity" ventilation.

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.(2) Among these measures, the End-Expiratory Lung Impedance (EELI), strongly correlated to the End-Expiratory Lung Volume (EELV), is the reflection of the FRC and can be dynamically monitored in real time at the patient's bedside(3). However, it has never been used in stable COPD patients on NIV, and could be an interesting tool for analyzing the impact of NIV on lung volumes.

The main objective is to evaluate the variation of EELV reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography, during a 20-minute session of NIV in patients with COPD at the stable state

The secondary objectives will be:

* To evaluate the variation of the EELV reflecting the FRC, via the EELI obtained by electrical impedance tomography, before, during and after a 20-minute session of NIV in stable-state COPD patients.
* Evaluate the relationship between the variation of PtCO2, and that of EELV under NIV, reflection of the FRC, via the EELI obtained by electrical impedance tomography.
* Identify responder and non-responder patient subgroups.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: End-Expiratory Lung Impedance (EELI) evolution during NIV sessions
timeFrame: Day 1
Secondary outcomes:
measure: End-Expiratory Lung Impedance (EELI) evolution before, during and NIV sessions
timeFrame: Day 1
measure: Transcutaneous capnia
timeFrame: Day 1
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Haut Lévêque, Centre Hospitalier Universitaire de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Leo GRASSION, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.