Lemiale Virginie, Mokart Djamel, Mayaux Julien, Lambert Jérôme, Rabbat Antoine, Demoule Alexandre, Azoulay Elie
Medical ICU, Saint Louis Teaching Hospital, AP-HP, 1 avenue Claude Vellefaux, 75010, Paris, France.
Medical-Surgical ICU, Institut Paoli Calmettes, 13000, Marseilles, France.
Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.
In immunocompromised patients, acute respiratory failure (ARF) is associated with high mortality, particularly when invasive mechanical ventilation (IMV) is required. In patients with severe hypoxemia, high-flow nasal oxygen (HFNO) therapy has been used as an alternative to delivery of oxygen via a Venturi mask. Our objective in the present study was to compare HFNO and Venturi mask oxygen in immunocompromised patients with ARF.
We conducted a multicenter, parallel-group randomized controlled trial in four intensive care units. Inclusion criteria were hypoxemic ARF and immunosuppression, defined as at least one of the following: solid or hematological malignancy, steroid or other immunosuppressant drug therapy, and HIV infection. Exclusion criteria were hypercapnia, previous IMV, and immediate need for IMV or noninvasive ventilation (NIV). Patients were randomized to 2 h of HFNO or Venturi mask oxygen.
The primary endpoint was a need for IMV or NIV during the 2-h oxygen therapy period. Secondary endpoints were comfort, dyspnea, and thirst, as assessed hourly using a 0-10 visual analogue scale. We randomized 100 consecutive patients, including 84 with malignancies, to HFNO (n = 52) or Venturi mask oxygen (n = 48). During the 2-h study treatment period, 12 patients required IMV or NIV, and we found no significant difference between the two groups (15 % with HFNO and 8 % with the Venturi mask, P = 0.36). None of the secondary endpoints differed significantly between the two groups.
In immunocompromised patients with hypoxemic ARF, a 2-h trial with HFNO improved neither mechanical ventilatory assistance nor patient comfort compared with oxygen delivered via a Venturi mask. However, the study was underpowered because of the low event rate and the one-sided hypothesis.
ClinicalTrials.gov identifier: NCT02424773 . Registered 20 April 2015.
在免疫功能低下的患者中,急性呼吸衰竭(ARF)与高死亡率相关,尤其是在需要有创机械通气(IMV)时。在严重低氧血症患者中,高流量鼻导管吸氧(HFNO)疗法已被用作通过文丘里面罩输氧的替代方法。我们在本研究中的目的是比较HFNO和文丘里面罩吸氧在免疫功能低下的ARF患者中的效果。
我们在四个重症监护病房进行了一项多中心、平行组随机对照试验。纳入标准为低氧血症性ARF和免疫抑制,定义为以下至少一项:实体或血液系统恶性肿瘤、类固醇或其他免疫抑制药物治疗以及HIV感染。排除标准为高碳酸血症、既往IMV以及立即需要IMV或无创通气(NIV)。患者被随机分为接受2小时的HFNO或文丘里面罩吸氧。
主要终点是在2小时的吸氧治疗期间需要IMV或NIV。次要终点是舒适度、呼吸困难和口渴,每小时使用0至10的视觉模拟量表进行评估。我们将100例连续患者(包括84例恶性肿瘤患者)随机分为HFNO组(n = 52)或文丘里面罩吸氧组(n = 48)。在2小时的研究治疗期间,12例患者需要IMV或NIV,我们发现两组之间无显著差异(HFNO组为15%,文丘里面罩组为8%,P = 0.36)。两组之间的次要终点均无显著差异。
在免疫功能低下的低氧血症性ARF患者中,与通过文丘里面罩输氧相比,2小时的HFNO试验既未改善机械通气辅助,也未改善患者舒适度。然而,由于事件发生率低和单侧假设,该研究的效能不足。
ClinicalTrials.gov标识符:NCT02424773。于2015年4月20日注册。