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NCT Number: NCT06510517

Mechanical Power Versus Diaphragmatic Excursion As a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients

The primary objective is to evaluate the mechanical power as a predictor of weaning of mechanical ventilation in COPD patients hospitalized in the respiratory intensive care unit of Assiut University Hospital.

The secondary objective is to compare between mechanical power and diaphragmatic excursion (DE) assessed by ultrasound as a predictor of weaning in these patients. Also, to investigate the association between MP and DE and mortality in these patients

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD), a public health problem that is characterized by persistent airflow limitation ,it develops when there is a significant exposure of irritants causing an inflammatory response in the lungs, it is a common cause of respiratory failure which require hospital admission that is associated with increased medical costs.

The World Health Organization reported that COPD was the fifth most common disease globally in 2020, with a prevalence of 7.8-19.7% in adults. Approximately, 60% of patients with COPD admitted with hypercapnic respiratory failure.

Acute exacerbations of chronic obstructive pulmonary disease (COPD) is characterized by acute worsening of respiratory symptoms associated with the development of severe airflow limitation, gas trapping, dynamic hyperinflation and intrinsic positive end-expiratory pressure (PEEPi). In the most severe cases, these exacerbations may cause acute respiratory failure, which may require mechanical ventilation.

The process of weaning from mechanical ventilation remains one of the most critical challenges in patients underwent mechanical ventilation in the intensive care unit (ICU). The multidisciplinary team must study the optimal time for weaning from the mechanical ventilator as premature weaning may lead to weaning failure and thus increase the risk of hospital acquired infections, costs of care, length of ICU stay, Morbidity and Mortality.

Current guidelines recommend several indices applied at the bedside to predict successful weaning from mechanical ventilation. A spontaneous breathing trial (SBT) is an appropriate way to prepare the patient for extubation; however, even after successful SBT, failure rates and subsequent reintubation can exceed 20% in the highest-risk patient.

Mechanical power (MP) is the energy delivered by the ventilator to the entire respiratory system per time unit and combines all factors affecting the energy load of the respiratory system, including pressure, tidal volume, flow rate and respiratory rate.

MP is primarily calculated as the product of the applied airway pressure and minute ventilation and can be used as an estimate of the workload exerted on the respiratory muscles during spontaneous breathing.

MP is a major determinant to ensure adequate gas exchange in the body and a key factor in assessing the ability of a patient to successfully wean from mechanical ventilation.

Therefore, a larger scale clinical study is needed to further verify the relationship between MP and weaning outcomes in all critically ill mechanically ventilated patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All COPD patients who are mechanically ventilated patients. Must be eligible for weaning according to European respiratory society 2016.

Exclusion criteria

  • Patients with Bronchiectasis, interstitial lung diseases, lung scarring.
  • Tracheostomized patients.

Treatment and study plan

Calculation of Mechanical Power.

Other

Total respiratory rate (RR). Positive end-expiratory pressure (PEEP) (the external or applied PEEP) recorded, not the total PEEP, or intrinsic PEEP. The plateau pressure (Pplat) was measured during an inspiratory pause on the ventilator. Peak inspiratory pressure (Ppeak) should be obtained while the patient is relaxed, not coughing or moving in bed. MP was calculated according to Gattinoni's simplified mechanical power equation as follows (3,8):

MP(J/min)=0.098×VT×RR×(Ppeak-0.5×ΔP).

Measurement Diaphragmatic Excursion after first SBT

Other

Chest ultrasound to assess diaphragmatic excursion (DE(. M-mode was used to record the movement of the diaphragm during tidal breathing when the sampling line and diaphragm were as vertical as possible (not < 70°). The data was measured from the first respiratory cycle at 0 min after SBT. The DE at 0 min, 5 min, and 30 min of SBT was respectively named as DE0, DE5, and DE30. The variation of right DE between each time point was named as ΔDE30-5 and ΔDE30-0. (7)

Primary outcomes

  1. Calculation of Mechanical Power before first trial of extubation.

    Time frame: 30 days

    Calculation of Mechanical Power before first trial of extubation for every mechanically ventilated patient before first trial of extubation.

Secondary outcomes

  1. value of Mechanical Power in died patients.

    Time frame: 30 days

    Mechanical Power as a predictor of patient's mortality.

  2. calculation of Mechanical Power in every Patients suffered from ventilator induced lung injury.

    Time frame: 30 days

    calculation of Mechanical Power and the number of Patients suffered from ventilator induced lung injury so study association between value of MP and possibility of VILI to be occurred.

  3. Calculation of other parameters of weaning as Respiratory rate, Rapid shallow breathing index and expiratory tidal volume.

    Time frame: 30 days

    Correlation analysis between mechanical power and other parameters of weaning in evaluation of prognosis in COPD patients.

  4. number of days for hospital stay and ICU stay for every Mechanically ventilated patients.

    Time frame: 30 days

    calculation of mechanical power and duration of hospital stay and ICU stay for each patient.

Study contacts

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

Mohamed Mamdouh Awad, Master Degree of Chest Diseses

CONTACT

[email protected]

2001023420225

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Mechanical Power Versus Diaphragmatic Excursion As a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients: Prospective Cohort Study

Acronym: weaning

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2024
Registry last updated
Dec 3, 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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