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

NCT06510517 | Not Yet Recruiting

• 1 other identifier: Mechanical Power in Weaning
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

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)

• Calculation of Mechanical Power before first trial of extubation.

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

  30 days

Secondary Outcomes (4)

• value of Mechanical Power in died patients.

  30 days

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

  30 days

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

  30 days

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

  30 days

Study Arms (2)

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.

Other: Calculation of Mechanical Power.; Other: Measurement Diaphragmatic Excursion after first SBT

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).

Interventions

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).

Paients with Successful weaning

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)

Paients with Successful weaning

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 of Assiut University Hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

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 Mamdouh Awad, Master Degree of Chest Diseses

CONTACT

2001023420225; mohamedmamdouh15794@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 19, 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