Optimizing the Assessment of Mechanical Ventilation by Integrating Advanced Monitoring Techniques [AVIM]

NCT06236685 | Enrolling By Invitation

• 1 other identifier: AVIM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to collect synchronized data from multiple monitoring techniques of mechanical ventilation (pressure/flow waves from the ventilator, electrical impedance tomography - EIT, esophageal pressure, capnography) in patients ventilated either on intensive care units or during anesthesia and evaluate the data by detailed mathematical analysis, to test three hypotheses:

1. 1.Various published methods of calculation of the expiratory time constant provide different results in most cases.
2. 2.Inhomogeneous ventilation (as described by EIT) affects the form of the expiratory flow curve and thus the calculated expiratory time constants.
3. 3.The calculation of mechanical energy transferred to the lungs is affected by the chosen technique and length of the inspiratory pause maneuver.

Conditions

Mechanical Ventilation Complication; Ventilator-Induced Lung Injury

Keywords

electrical impedance tomography; expiratory time constant; mechanical energy; lung protective ventilation; ventilator-induced lung injury; expiratory flow; inspiratory hold maneuver

Outcome Measures

Primary Outcomes (2)

• Expiratory time constant

  Time \[in seconds\], in which the lungs exhale 63% of the total volume.

  2 minutes after an intervention or a change in the ventilator settings

• Mechanical energy transferred to the lungs

  Mechanical energy (alternatively referred to as mechanical work) \[in Joules\] is the energy delivered to the respiratory system during a single inspiration cycle.

  2 minutes after an intervention or a change in the ventilator settings

Other Outcomes (1)

• Regional signals of electrical impedance tomography

  2 minutes after an intervention or a change in the ventilator settings

Study Arms (2)

General anesthesia

EXPERIMENTAL

Patients undergoing general anesthesia with mechanical ventilation will be monitored by electrical impedance tomography in addition to standard monitoring. Moreover, esophageal pressure catheter will be used in cases where indicated by clinician or in case of an indication of nasogastric tube, as esophageal pressure can be measured by a combined catheter.

Device: Electric impedance tomography

Intensive Care Unit

EXPERIMENTAL

Patients ventilated in the ICU for various reasons will receive standard care, including advanced monitoring of mechanical ventilation.

Device: Electric impedance tomography

Interventions

Electric impedance tomography DEVICE

EIT is rarely used during general anesthesia for standard procedures. In the anesthesia arm, all patients will be monitored by EIT.

Also known as: EIT

General anesthesia; Intensive Care Unit

Eligibility Criteria

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

You may qualify if:

• mechanical ventilation for anesthesia or in intensive care unit

You may not qualify if:

• disagreement with enrollment or incapacity to understand the patient information leaflet
• contraindications to electric impedance tomography (skin lesions in the place of electrode placement etc.)
• necessity to use a defined ventilator setting outside the study protocol

Sponsors & Collaborators

• Czech Technical University in Prague: lead
• Military University Hospital, Prague: collaborator

Study Sites (1)

Military University Hospital

Prague, 16902, Czechia

Location

Related Publications (5)

• Karagiannidis C, Waldmann AD, Roka PL, Schreiber T, Strassmann S, Windisch W, Bohm SH. Regional expiratory time constants in severe respiratory failure estimated by electrical impedance tomography: a feasibility study. Crit Care. 2018 Sep 21;22(1):221. doi: 10.1186/s13054-018-2137-3.

  PMID: 30236123 BACKGROUND

• Brunner JX, Laubscher TP, Banner MJ, Iotti G, Braschi A. Simple method to measure total expiratory time constant based on the passive expiratory flow-volume curve. Crit Care Med. 1995 Jun;23(6):1117-22. doi: 10.1097/00003246-199506000-00019.

  PMID: 7774225 BACKGROUND

• Candik P, Rybar D, Depta F, Sabol F, Kolesar A, Galkova K, Torok P, Donicova V, Imrecze S, Nosal M, Donic V. Relationship between dynamic expiratory time constant tau(edyn) and parameters of breathing cycle in pressure support ventilation mode. Physiol Res. 2018 Dec 18;67(6):875-879. doi: 10.33549/physiolres.933750. Epub 2018 Sep 11.

  PMID: 30204464 BACKGROUND

• Henderson WR, Molgat-Seon Y, Vos W, Lipson R, Ferreira F, Kirby M, Holsbeke CV, Dominelli PB, Griesdale DE, Sekhon M, Coxson HO, Mayo J, Sheel AW. Functional respiratory imaging, regional strain, and expiratory time constants at three levels of positive end expiratory pressure in an ex vivo pig model. Physiol Rep. 2016 Dec;4(23):e13059. doi: 10.14814/phy2.13059.

  PMID: 27923979 BACKGROUND

• Vogt B, Pulletz S, Elke G, Zhao Z, Zabel P, Weiler N, Frerichs I. Spatial and temporal heterogeneity of regional lung ventilation determined by electrical impedance tomography during pulmonary function testing. J Appl Physiol (1985). 2012 Oct;113(7):1154-61. doi: 10.1152/japplphysiol.01630.2011. Epub 2012 Aug 16.

  PMID: 22898553 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Karel Roubík, prof.

  Czech Technical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted on patients provided with mechanical ventilation either on intensive care units or during anesthesia. Extended monitoring of ventilation, including electric impedance tomography and esophageal pressure readings will be applied.

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: April 22, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)