NCT06531005

Brief Summary

The study aims to research the values of mechanical power, driving pressure, and elastic power in predicting the duration of mechanical ventilation in critically ill patients undergoing invasive mechanical ventilation. This will help determine which patients may be considered for early extubation, which patients should wait for extubation, and the patients where extubation is anticipated to be prolonged, attention should be paid to initiating preparations for alternative treatment methods like tracheostomy early.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 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

April 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

July 24, 2024

Last Update Submit

July 28, 2024

Conditions

Acute Respiratory FailureInvasive Mechanical Ventilation

Keywords

respiratory failureextubationmechanical powerelastic powerrepiratory mechanicsoutcome

Outcome Measures

Primary Outcomes (1)

  • extubation time

    time patients will be extubated after intubation

    seven days

Secondary Outcomes (3)

  • mortality

    28 days

  • acute renal failure

    one month

  • ICU/ hospital length of stay

    three months

Eligibility Criteria

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

All patients who have recently been intubated for acute respiratory failure and admitted to participating ICUs will be screened and included in the study if eligible.

You may qualify if:

  • consenting patients who have recently been intubated for acute respiratory failure

You may not qualify if:

  • patients with lung cancer/ lung metastasis
  • ECMO
  • death within 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Medicine

Altindağ, Ankara, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • Adhikari NK, Fowler RA, Bhagwanjee S, Rubenfeld GD. Critical care and the global burden of critical illness in adults. Lancet. 2010 Oct 16;376(9749):1339-46. doi: 10.1016/S0140-6736(10)60446-1. Epub 2010 Oct 11.

    PMID: 20934212BACKGROUND

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

    PMID: 10793162BACKGROUND

  • de Durante G, del Turco M, Rustichini L, Cosimini P, Giunta F, Hudson LD, Slutsky AS, Ranieri VM. ARDSNet lower tidal volume ventilatory strategy may generate intrinsic positive end-expiratory pressure in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2002 May 1;165(9):1271-4. doi: 10.1164/rccm.2105050.

    PMID: 11991877BACKGROUND

  • Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

    PMID: 25693014BACKGROUND

  • Marini JJ, Rocco PRM, Gattinoni L. Static and Dynamic Contributors to Ventilator-induced Lung Injury in Clinical Practice. Pressure, Energy, and Power. Am J Respir Crit Care Med. 2020 Apr 1;201(7):767-774. doi: 10.1164/rccm.201908-1545CI.

    PMID: 31665612BACKGROUND

  • Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.

    PMID: 27620287RESULT

  • Xie Y, Yan Y, Shi J, Luo J, Wang Y, Chen H, Li X. Elastic power, a novel predictor of the severity and prognosis of ARDS. J Crit Care. 2023 Dec;78:154380. doi: 10.1016/j.jcrc.2023.154380. Epub 2023 Jul 20.

    PMID: 37480658RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Neriman D Altıntaş, Professor

    https://avesis.ankara.edu.tr/ndaltintas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

nuri işler, res.doctor

CONTACT

+905078339595nuriisler1753@gmail.com

Nazlıhan B DÜNDAR, Ass.Prof.

CONTACT

+905054790794nazlihan_boyaci@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

July 24, 2024

First Posted

July 31, 2024

Study Start

April 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

TU(1)