Lall Ranjit, Hamilton Patrick, Young Duncan, Hulme Claire, Hall Peter, Shah Sanjoy, MacKenzie Iain, Tunnicliffe William, Rowan Kathy, Cuthbertson Brian, McCabe Chris, Lamb Sallie
Warwick Clinical Trials Unit, University of Warwick, Warwick, UK.
University of Leeds, Leeds, UK.
Health Technol Assess. 2015 Mar;19(23):1-177, vii. doi: 10.3310/hta19230.
Patients with the acute respiratory distress syndrome (ARDS) require artificial ventilation but this treatment may produce secondary lung damage. High-frequency oscillatory ventilation (HFOV) may reduce this damage.
To determine the clinical benefit and cost-effectiveness of HFOV in patients with ARDS compared with standard mechanical ventilation.
A parallel, randomised, unblinded clinical trial.
UK intensive care units.
Mechanically ventilated patients with a partial pressure of oxygen in arterial blood/fractional concentration of inspired oxygen (P : F) ratio of 26.7 kPa (200 mmHg) or less and an expected duration of ventilation of at least 2 days at recruitment.
Treatment arm HFOV using a Novalung R100(®) ventilator (Metran Co. Ltd, Saitama, Japan) ventilator until the start of weaning. Control arm Conventional mechanical ventilation using the devices available in the participating centres.
The primary clinical outcome was all-cause mortality at 30 days after randomisation. The primary health economic outcome was the cost per quality-adjusted life-year (QALY) gained.
One hundred and sixty-six of 398 patients (41.7%) randomised to the HFOV group and 163 of 397 patients (41.1%) randomised to the conventional mechanical ventilation group died within 30 days of randomisation (p = 0.85), for an absolute difference of 0.6% [95% confidence interval (CI) -6.1% to 7.5%]. After adjustment for study centre, sex, Acute Physiology and Chronic Health Evaluation II score, and the initial P : F ratio, the odds ratio for survival in the conventional ventilation group was 1.03 (95% CI 0.75 to 1.40; p = 0.87 logistic regression). Survival analysis showed no difference in the probability of survival up to 12 months after randomisation. The average QALY at 1 year in the HFOV group was 0.302 compared to 0.246. This gives an incremental cost-effectiveness ratio (ICER) for the cost to society per QALY of £88,790 and an ICER for the cost to the NHS per QALY of £ 78,260.
The use of HFOV had no effect on 30-day mortality in adult patients undergoing mechanical ventilation for ARDS and no economic advantage. We suggest that further research into avoiding ventilator-induced lung injury should concentrate on ventilatory strategies other than HFOV.
Current Controlled Trials ISRCTN10416500.
急性呼吸窘迫综合征（ARDS）患者需要人工通气，但这种治疗可能会导致继发性肺损伤。高频振荡通气（HFOV）可能会减少这种损伤。
确定与标准机械通气相比，HFOV对ARDS患者的临床益处和成本效益。
一项平行、随机、非盲的临床试验。
英国重症监护病房。
动脉血氧分压/吸入氧分数（P:F）比值为26.7kPa（200mmHg）或更低且预计通气时间至少为2天的机械通气患者。
治疗组 使用Novalung R100（®）呼吸机（日本埼玉县Metran有限公司）进行HFOV，直至开始撤机。对照组 使用参与中心现有的设备进行传统机械通气。
主要临床结局是随机分组后30天的全因死亡率。主要卫生经济结局是每获得一个质量调整生命年（QALY）的成本。
随机分组到HFOV组的398例患者中有166例（41.7%），随机分组到传统机械通气组的397例患者中有163例（41.1%）在随机分组后30天内死亡（p = 0.85），绝对差异为0.6%[95%置信区间（CI）-6.1%至7.5%]。在对研究中心、性别、急性生理与慢性健康状况评分II以及初始P:F比值进行调整后，传统通气组的生存比值比为1.03（95%CI 0.75至1.40；p = 0.87，逻辑回归）。生存分析显示，随机分组后长达12个月的生存概率没有差异。HFOV组1年时的平均QALY为0.302，而传统机械通气组为0.246。这使得每QALY的社会成本增量成本效益比（ICER）为88,790英镑，每QALY的英国国家医疗服务体系（NHS）成本ICER为78,260英镑。
对于因ARDS接受机械通气的成年患者，使用HFOV对30天死亡率没有影响，也没有经济优势。我们建议，关于避免呼吸机诱导性肺损伤的进一步研究应集中在HFOV以外的通气策略上。
当前受控试验ISRCTN10416500。
