Department of Anesthesia, University of Turin, San Giovanni Battista Molinette Hospital, Corso Dogliotti 14, Turin 10126, Italy.
JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796.
Many potential donor lungs deteriorate between the time of brain death and evaluation for transplantation suitability, possibly because of the ventilatory strategy used after brain death.
To test whether a lung protective strategy increases the number of lungs available for transplantation.
DESIGN, SETTING, AND PATIENTS: Multicenter randomized controlled trial of patients with beating hearts who were potential organ donors conducted at 12 European intensive care units from September 2004 to May 2009 in the Protective Ventilatory Strategy in Potential Lung Donors Study. Interventions Potential donors were randomized to the conventional ventilatory strategy (with tidal volumes of 10-12 mL/kg of predicted body weight, positive end-expiratory pressure [PEEP] of 3-5 cm H(2)O, apnea tests performed by disconnecting the ventilator, and open circuit for airway suction) or the protective ventilatory strategy (with tidal volumes of 6-8 mL/kg of predicted body weight, PEEP of 8-10 cm H(2)O, apnea tests performed by using continuous positive airway pressure, and closed circuit for airway suction).
The number of organ donors meeting eligibility criteria for harvesting, number of lungs harvested, and 6-month survival of lung transplant recipients.
The trial was stopped after enrolling 118 patients (59 in the conventional ventilatory strategy and 59 in the protective ventilatory strategy) because of termination of funding. The number of patients who met lung donor eligibility criteria after the 6-hour observation period was 32 (54%) in the conventional strategy vs 56 (95%) in the protective strategy (difference of 41% [95% confidence interval {CI}, 26.5% to 54.8%]; P <.001). The number of patients in whom lungs were harvested was 16 (27%) in the conventional strategy vs 32 (54%) in the protective strategy (difference of 27% [95% CI, 10.0% to 44.5%]; P = .004). Six-month survival rates did not differ between recipients who received lungs from donors ventilated with the conventional strategy compared with the protective strategy (11/16 [69%] vs 24/32 [75%], respectively; difference of 6% [95% CI, -22% to 32%]).
Use of a lung protective strategy in potential organ donors with brain death increased the number of eligible and harvested lungs compared with a conventional strategy.
clinicaltrials.gov Identifier: NCT00260676.
许多潜在的供体肺在脑死亡和评估移植适宜性之间的时间恶化，可能是由于脑死亡后使用的通气策略。
测试肺保护策略是否增加了可供移植的肺数量。
设计、地点和患者：在欧洲 12 个重症监护病房进行的多中心随机对照试验，对潜在器官捐献者进行了有心跳的患者的研究，这些患者可能是脑死亡后的潜在供体。在潜在肺供体通气策略研究中，潜在供体被随机分配到常规通气策略（潮气量 10-12ml/kg 预测体重，呼气末正压[PEEP]3-5cmH2O，通过断开呼吸机进行呼吸暂停试验，以及用于气道抽吸的开放回路）或保护性通气策略（潮气量 6-8ml/kg 预测体重，PEEP 8-10cmH2O，通过使用持续气道正压进行呼吸暂停试验，以及用于气道抽吸的闭合回路）。
符合器官采集资格标准的供体数量、采集的肺数量以及肺移植受者 6 个月的生存率。
由于资金终止，在纳入 118 名患者（常规通气策略 59 名，保护性通气策略 59 名）后，该试验停止。在 6 小时观察期后，符合肺供体资格标准的患者人数在常规策略中为 32 人（54%），在保护性策略中为 56 人（95%）（差异为 41%[95%置信区间{CI}，26.5%至 54.8%]；P <.001）。在常规策略中，有 16 名（27%）患者采集了肺，而在保护性策略中，有 32 名（54%）患者采集了肺（差异为 27%[95% CI，10.0%至 44.5%]；P =.004）。接受常规通气策略供体肺的受者与接受保护性通气策略供体肺的受者 6 个月生存率无差异（分别为 16/16[69%]和 32/32[75%]；差异为 6%[95% CI，-22%至 32%]）。
与常规策略相比，脑死亡后对潜在器官供体使用肺保护策略增加了符合条件和采集的肺数量。
clinicaltrials.gov 标识符：NCT00260676。
