Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA

NCT ID: NCT05990348

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-09-30

Brief Summary

the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) . Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive. However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.

Detailed Description

Respiratory muscles dysfunction is one of the main causes leading to failure of weaning from mechanical ventilation (MV) in critically ill patients. Muscular activity is important during the inspiratory phase of ventilation, which is mainly due to diaphragm and external intercostal muscles. Diaphragm dysfunction is frequent among critically ill patients and ranges from 33 to 95% . Although several indexes have been investigated to help clinician in identifying its disturbance, their clinical value is controversial . External intercostal muscles dysfunction epidemiology is unknown because of lack of non-invasive tool to investigate such condition. However, the echography assessment of intercostal muscles thickening fraction (TFic) has shown promising results in this field as a non-invasive tool to assess inspiratory muscle function and predict weaning failure .

On the other hand, the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) [. Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive . A recent study suggests that EAdi and derived parameters, may be helpful to predict weaning failure in chronic obstructive pulmonary disease (COPD) patients .

However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.

the aim of this study will be the comparison of TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU and the assessment of the inspiratory effort parameters and the occurrence of respiratory asynchrony in patients with difficult weaning from MV admitted in ICU.

Conditions

Respiratory Failure; Weaning Failure

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Interventions

difficult weaning patients

intercostal thickening fraction values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients who have failed at least one weaning attempt
• mechanical ventilation for at least 24 hours

Exclusion Criteria

• Pregnancy
• Obesity (Body Mass Index > 35 kg/m2)
• Contraindication to the insert of a nasogastric tube
• Neuromuscular diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

SPINAZZOLA GIORGIA

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Giorgia Spinazzola

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

giorgia GS spinazzola, md

Role: CONTACT

giorgia.spinazzola@policlinicogemelli.it

0630154507

gianmarco gm maresca, md

Role: CONTACT

gianmarco.maresca@policlinicogemelli.it

0630154507

Facility Contacts

giorgia spinazzola

Role: primary

giorgia.spinazzola@policlinicogemelli.it

+393297813925

References

Abdelwahed WM, Abd Elghafar MS, Amr YM, Alsherif SEI, Eltomey MA. Prospective study: Diaphragmatic thickness as a predictor index for weaning from mechanical ventilation. J Crit Care. 2019 Aug;52:10-15. doi: 10.1016/j.jcrc.2019.03.006. Epub 2019 Mar 15. No abstract available.

Reference Type: RESULT

PMID: 30904733 (View on PubMed)

Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.

Reference Type: RESULT

PMID: 27677861 (View on PubMed)

Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.

Reference Type: RESULT

PMID: 32516052 (View on PubMed)

Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.

Reference Type: RESULT

PMID: 25879592 (View on PubMed)

Other Identifiers

4856

Identifier Type: -

Identifier Source: org_study_id