the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation.

Официальное название

the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation :a Randomized Double Blinded Study.

Обзор

The goal of this clincal trial is to learn if doxapram is effective in weaning in adults on mechanical ventilation. The objectives of this study: * Evaluate the effect of doxapram on diaphragmatic function (assessed by DE)during weaning from mechanical ventilation. * Assess the impact of doxapram on respiratory muscle sterngth. * Mointor adverse effects associated with doxapram administration. Researchers will compare expermental group(intervenous doxapram during weaning)with control group(saline infusion)during weaning. The patients who fulfull criteria of weaning will be subjected to our clincal trial and put on spontanous breathing trial for 120mins using positive end expiratory pressure (peep)5 cmh2o,pressure support 5cm h2o and fio2 0.3.By the end of the SBTthe patient will be extubated if ventilator parameters and vital signs were maintained within 20%of baseline values. The patients will be followed up after extubation and afailed weaning will be defined as the neeed for either invasive or non invasive ventilation for 72 after extubation or failed SBT.

Вмешательства

• Препарат Doxapram
  Doxapram is used as a respiatory stimulant intended to enhance respiratory drive and diaphragmatic activity durig ventilator weaning.

Первичные конечные точки

• - Diaphragmatic excursion (DE) measured by ultrasound. [Срок оценки: Baseline(immediately before initiation of weaning trial) ,and at 15 minutes,60 minutes,and 120 minutes after initiation of weaning trial.]

Вторичные конечные точки (2)

• Maximal Inspiratory Pressure(MIP) [Срок оценки: Baseline and during weaning trial up to 120 minutes.]
• Weaning Success Rate [Срок оценки: Within 48hr after extubation.]

Критерии участия

Критерии включения

• Adults (≥18 years) on mechanical ventilation for >48 hours.
• Deemed ready for weaning by the clinical team: Defined as RSBI <105, P/F ratio >200, hemodynamic stability.
• Stable hemodynamics and adequate oxygenation (PaO₂/FiO₂ >150)

Критерии исключения

• Severe neurological impairment :Defined as GCS ≤8 or spinal cord injury above T5 .

• Known hypersensitivity to doxapram.
• Pregnancy or lactation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Wu JQ, Wang YX, Su D, Shao TH, Ding XX, Sun T, Cui N, Yu ZB. EFFECTS OF LEVOSIMENDAN ON DIAPHRAGMATIC DYSFUNCTION IN PATIENTS WITH SEPSIS. Shock. 2024 Jul 1;62(1):63-68. doi: 10.1097/SHK.0000000000002372. Epub 2024 Apr 8. PMID 38661179
• Moser KM, Luchsinger PC, Adamson JS, McMahon SM, Schlueter DP, Spivack M, Weg JG. Respiratory stimulation with intravenous doxapram in respiratory failure. A double-blind co-operative study. N Engl J Med. 1973 Mar 1;288(9):427-31. doi: 10.1056/NEJM197303012880901. No abstract available. PMID 4567320
• Eltrabili HH, Hasanin AM, Soliman MS, Lotfy AM, Hamimy WI, Mukhtar AM. Evaluation of Diaphragmatic Ultrasound Indices as Predictors of Successful Liberation From Mechanical Ventilation in Subjects With Abdominal Sepsis. Respir Care. 2019 May;64(5):564-569. doi: 10.4187/respcare.06391. Epub 2019 Jan 22. PMID 30670667
• de Waal CG, Hutten GJ, Kraaijenga JV, de Jongh FH, van Kaam AH. Doxapram Treatment and Diaphragmatic Activity in Preterm Infants. Neonatology. 2019;115(1):85-88. doi: 10.1159/000493359. Epub 2018 Oct 23. PMID 30352445
• Roesthuis L, van der Hoeven H, Sinderby C, Frenzel T, Ottenheijm C, Brochard L, Doorduin J, Heunks L. Effects of levosimendan on respiratory muscle function in patients weaning from mechanical ventilation. Intensive Care Med. 2019 Oct;45(10):1372-1381. doi: 10.1007/s00134-019-05767-y. Epub 2019 Oct 1. PMID 31576436
• Roesthuis LH, van der Hoeven JG, van Hees HWH, Schellekens WM, Doorduin J, Heunks LMA. Recruitment pattern of the diaphragm and extradiaphragmatic inspiratory muscles in response to different levels of pressure support. Ann Intensive Care. 2020 May 29;10(1):67. doi: 10.1186/s13613-020-00684-6. PMID 32472272
• Helmy MA, Magdy Milad L, Osman SH, Ali MA, Hasanin A. Diaphragmatic excursion: A possible key player for predicting successful weaning in patients with severe COVID-19. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100875. doi: 10.1016/j.accpm.2021.100875. Epub 2021 Apr 30. No abstract available. PMID 33940248
• Adolf Helmy M, Magdy Milad L, Hasanin A, Mostafa M. The novel use of diaphragmatic excursion on hospital admission to predict the need for ventilatory support in patients with coronavirus disease 2019. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100976. doi: 10.1016/j.accpm.2021.100976. Epub 2021 Nov 5. PMID 34748940

Идентификаторы

NCT: NCT07637149 · effect of doxapram in weaning.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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