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NCT Number: NCT06531005

Assessment of Ventilation Parameters for Extubation Prediction in ICU

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Medicine

Altindağ, Ankara, 06230, Turkey (Türkiye)

Location status: Recruiting

Location contact

Neriman D Altıntaş, Prof.Dr.

CONTACT

[email protected]

+905326640331

Nuri İşler, Resid.Dr

CONTACT

+905078339595

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. extubation time

    Time frame: seven days

    time patients will be extubated after intubation

Secondary outcomes

  1. mortality

    Time frame: 28 days

    28 day mortality

  2. acute renal failure

    Time frame: one month

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

  3. ICU/ hospital length of stay

    Time frame: three months

    ICU/ hospital length of stay

Study contacts

Contact information is provided by the study sponsor or research team.

Nazlıhan B DÜNDAR, Ass.Prof.

CONTACT

[email protected]

+905054790794

nuri işler, res.doctor

CONTACT

[email protected]

+905078339595

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

  • Gazi University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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