Assessment of Ventilation Parameters for Extubation Prediction in ICU

Recruiting

• Conditions: Acute Respiratory Failure; Invasive Mechanical Ventilation

• Registration Number: NCT06531005
• Lead Sponsor: Ankara University

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.

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.

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-28
• Last Update Submitted: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
extubation time	seven days	time patients will be extubated after intubation

Secondary Outcome Measures

Name	Time	Method
ICU/ hospital length of stay	three months	ICU/ hospital length of stay
mortality	28 days	28 day mortality
acute renal failure	one month	Number of patients who developed acute kidney injury according to KDIGO guidelines

Trial Locations

Locations (1)

Ankara University Faculty of Medicine; 🇹🇷 Altindağ, Ankara, Turkey