Mechanical Power Versus Diaphragmatic Excursion As a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients
NCT ID: NCT06510517
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
84 participants
OBSERVATIONAL
2024-12-01
2026-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Paients with Successful weaning
The procedure of weaning from mechanical ventilation will be considered as early as possible. Patients who will be mechanically ventilated \>24 h will be underwent daily screen of subjective and objective indices for assessment of readiness to wean. Weaning will be conducted according to European Respiratory Society guidelines (ERS) (5).
The criteria for successful extubation: successful extubation was defined as the ability to maintain spontaneous breathing for at least 48 h, without any ventilatory support.
Calculation of Mechanical Power.
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
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)
Patients with failed weaning
the reconnection to ventilator (invasive or noninvasive) within 48 h due to respiratory failure or other reasons. Extubation and the reconnection to ventilator were all based on SBT results and physicians' decision (5,9).
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Calculation of Mechanical Power.
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
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Tracheostomized patients.
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Mamdouh Moustafa
Assistant Lecturer
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Yu J, Lee MR, Chen CT, Lin YT, How CK. Predictors of Successful Weaning from Noninvasive Ventilation in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Single-Center Retrospective Cohort Study. Lung. 2021 Oct;199(5):457-466. doi: 10.1007/s00408-021-00469-z. Epub 2021 Aug 21.
Mohamed-Hussein AAR, Makhlouf HA, Selim ZI, Gamaleldin Saleh W. Association between hand grip strength with weaning and intensive care outcomes in COPD patients: A pilot study. Clin Respir J. 2018 Oct;12(10):2475-2479. doi: 10.1111/crj.12921. Epub 2018 Sep 23.
Yan Y, Xie Y, Chen X, Sun Y, Du Z, Wang Y, Li X. Mechanical power is associated with weaning outcome in critically ill mechanically ventilated patients. Sci Rep. 2022 Nov 16;12(1):19634. doi: 10.1038/s41598-022-21609-2.
Azizi BA, Munoz-Acuna R, Suleiman A, Ahrens E, Redaelli S, Tartler TM, Chen G, Jung B, Talmor D, Baedorf-Kassis EN, Schaefer MS. Mechanical power and 30-day mortality in mechanically ventilated, critically ill patients with and without Coronavirus Disease-2019: a hospital registry study. J Intensive Care. 2023 Apr 6;11(1):14. doi: 10.1186/s40560-023-00662-7.
Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
Leonov Y, Kisil I, Perlov A, Stoichev V, Ginzburg Y, Nazarenko A, Gimelfarb Y. Predictors of successful weaning in patients requiring extremely prolonged mechanical ventilation. Adv Respir Med. 2020;88(6):477-484. doi: 10.5603/ARM.a2020.0151.
Zhang X, Yuan J, Zhan Y, Wu J, Liu B, Zhang P, Yu T, Wang Z, Jiang X, Lu W. Evaluation of diaphragm ultrasound in predicting extubation outcome in mechanically ventilated patients with COPD. Ir J Med Sci. 2020 May;189(2):661-668. doi: 10.1007/s11845-019-02117-1. Epub 2019 Nov 6.
Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
Akella P, Voigt LP, Chawla S. To Wean or Not to Wean: A Practical Patient Focused Guide to Ventilator Weaning. J Intensive Care Med. 2022 Nov;37(11):1417-1425. doi: 10.1177/08850666221095436. Epub 2022 Jul 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Mechanical Power in Weaning
Identifier Type: -
Identifier Source: org_study_id