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Status unknownNCT06531005Updated Jul 31, 2024

Assessment of Ventilation Parameters for Extubation Prediction in ICU

An observational study in Acute Respiratory Failure and Invasive Mechanical Ventilation, sponsored by Ankara University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Ankara University · Observational

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Due to acute respiratory failure, mechanical ventilation support is provided to over 20 million patients worldwide. Therefore, various studies are being conducted to prevent ventilation-associated lung injury in patients receiving invasive mechanical ventilation, especially in conditions such as acute respiratory distress syndrome (ARDS).

Initially, protective mechanical ventilation studies have shown that keeping plateau pressure (Pplat), reflecting static compliance, below 30 cmH2O along with low tidal volume reduces all-cause mortality. Subsequent studies have defined driving pressure as Pplato-PEEP, suggesting that keeping driving pressure below 15 cmH2O may reduce excessive strain on healthy lung tissue and the development of ventilator-associated lung injury.

In 2016, Gattinoni and colleagues defined mechanical power as the power applied by the ventilator to the entire respiratory system per minute during mechanical ventilation, prompting research into the relationship between mechanical power and mortality, particularly in ARDS.

Mechanical power consists of three components: energy delivered with each breath when PEEP is applied, energy applied to overcome airway resistance, and elastic energy delivered with each tidal breath.

Finally, Yongpeng Xie and colleagues hypothesized that elastic power, normalized by compliance, has a more significant relationship with mortality in ARDS patients. Studies on mechanical power, driving pressure, and elastic power typically focus on values measured on the first day of intubation and are predominantly conducted in ARDS patients.

By including all patients under invasive mechanical ventilation in the study, the importance of measuring and monitoring mechanical ventilator parameters (mechanical power, driving pressure, and elastic power) at 0th, 24th, and 48th hours to predict extubation within the first week is being determined. This aims to identify when early extubation should be considered, when extubation should be delayed, and to prepare for alternative treatment options like tracheostomy in cases where extubation might be prolonged.

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Conditions studied

  • Acute Respiratory Failure
  • Invasive Mechanical Ventilation

Keywords

  • respiratory failure
  • extubation
  • mechanical power
  • elastic power
  • repiratory mechanics
  • outcome
03

In context

Respiratory Insufficiency

1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 556 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Ankara University is the lead sponsor of 318 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. extubation time

    time patients will be extubated after intubation

    Time frame: seven days

Secondary outcomes

  1. mortality

    28 day mortality

    Time frame: 28 days

  2. acute renal failure

    Number of patients who developed acute kidney injury according to KDIGO guidelines

    Time frame: one month

  3. ICU/ hospital length of stay

    ICU/ hospital length of stay

    Time frame: three months

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Study locations

1 of 1 sites recruiting
  • Ankara University Faculty of Medicine
    Altindağ, Ankara 06230, Turkey (Türkiye)
    • Neriman D Altıntaş, Prof.Dr. · Contact · defne98hac@yahoo.com · +905326640331
    • Nuri İşler, Resid.Dr · Contact · +905078339595
    Recruiting
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References and documents

Publications

  • 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. PubMed 20934212 ↗
  • 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. PubMed 10793162 ↗
  • 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. PubMed 11991877 ↗
  • 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. PubMed 25693014 ↗
  • 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. PubMed 31665612 ↗
  • 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. PubMed 27620287 ↗
  • 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. PubMed 37480658 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Jan 2025, 9 months after the start.

Of 271 non-industry observational studies under Respiratory Insufficiency, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 49. This study's planned 9 months is below that.

Counting every sponsor, half of 288 studies reached it within 21 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2024
First posted
Jul 31, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Jan 1, 2025
CompletionEst.
Feb 1, 2025
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06531005
Lead sponsor
Ankara University
Collaborators
Gazi University
Responsible party
Nuri Isler (Research assistant, Ankara University) — Principal investigator
First posted
Jul 31, 2024
Start date
Apr 1, 2024
Primary completion
Jan 1, 2025 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Jul 31, 2024

Study contacts

nuri işler, res.doctor
Contact
nuriisler1753@gmail.com
+905078339595
Nazlıhan B DÜNDAR, Ass.Prof.
Contact
nazlihan_boyaci@yahoo.com
+905054790794
Neriman D Altıntaş, Professor
principal investigator · https://avesis.ankara.edu.tr/ndaltintas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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