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

NCT06493929 | Not Yet Recruiting

• 1 other identifier: Mechanical Power
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mechanical Power

Keywords

Mechanical power; Weaning

Outcome Measures

Primary Outcomes (1)

• 1. Evaluation the efficacy of MP as a predictor of weaning for COPD patients.

  Evaluation the efficacy of MP as a predictor of weaning for COPD patients.

  2 years

Secondary Outcomes (4)

• 1-MP as a predictor of patient's mortality.

  2 years

• 2-MP and duration of hospital stay and ICU stay.

  2 years

• 3-MP and ventilator induced lung injury.

  2 years

• 4-Correlation analysis between mechanical power and other parameters of weaning: Respiratory rate, Rapid shallow breathing index, Heart Rate and Expiratory Tidal volume in evaluation of prognosis in COPD patients.

  2 years

Study Arms (2)

Paients with Successful weaning from Mechanical Ventilation

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.

Other: Chest ultrasound; Other: Calculation of Mechanical Power on the first day of intubation and before First trial of weaning:

Patients with failed weaning from Mechanical Ventilation

failure extubation was defined as 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).

Interventions

Chest ultrasound OTHER

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.

Paients with Successful weaning from Mechanical Ventilation

Calculation of Mechanical Power on the first day of intubation and before First trial of weaning: 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).

Paients with Successful weaning from Mechanical Ventilation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients who are mechanically ventilated in Respiratory ICU in Assiut University Hospital.

You may qualify if:

• All COPD mechanically ventilated patients admitted to respiratory intensive care unit and eligible for weaning according to European respiratory society 2016 (5).

You may not qualify if:

• \- 1. Patients with associated lung pathology that may alter lung mechanics (Bronchiectasis, interstitial lung diseases, lung scarring) will be excluded from the study.
• \. Tracheostomized patients.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (9)

• 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.

  PMID: 34420091 BACKGROUND

• 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.

  PMID: 29931773 BACKGROUND

• 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.

  PMID: 36385129 BACKGROUND

• 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.

  PMID: 37024938 BACKGROUND

• 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.

  PMID: 17470624 BACKGROUND

• 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.

  PMID: 33393639 BACKGROUND

• 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.

  PMID: 31691888 BACKGROUND

• 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.

  PMID: 34597688 BACKGROUND

• 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.

  PMID: 35815895 BACKGROUND

Central Study Contacts

Mohamed M Moustafa Awad, Assistant Lecturer

CONTACT

0l023420225; mohamedmamdouh15794@gmail.com

Hoda A Makhlouf, Professor

CONTACT

01001529442

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)