NCT05990348

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2.9 years

First QC Date

February 24, 2023

Last Update Submit

October 17, 2024

Conditions

Respiratory FailureWeaning Failure

Outcome Measures

Primary Outcomes (1)

  • intercostal thickening fraction

    intercostal thickening fraction values during PSV and NAVA

    From date of enrollment until the date of extubation (up to seven days)

Interventions

difficult weaning patientsOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients on mechanical ventilation (MV) for at least 24 hours, who have failed at least one weaning attempt, hospitalized at the Intensive Care Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giorgia Spinazzola

Rome, 00168, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30904733RESULT

  • 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.

    PMID: 27677861RESULT

  • 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.

    PMID: 32516052RESULT

  • 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.

    PMID: 25879592RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Central Study Contacts

giorgia GS spinazzola, md

CONTACT

0630154507giorgia.spinazzola@policlinicogemelli.it

gianmarco gm maresca, md

CONTACT

0630154507gianmarco.maresca@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 24, 2023

First Posted

August 14, 2023

Study Start

July 1, 2022

Primary Completion

May 30, 2025

Study Completion

September 30, 2025

Last Updated

October 18, 2024

Record last verified: 2024-10

Locations

IT(1)