Melone Marie-Anne, Heming Nicholas, Meng Paris, Mompoint Dominique, Aboab Jerôme, Clair Bernard, Salomon Jerôme, Sharshar Tarek, Orlikowski David, Chevret Sylvie, Annane Djillali
Respiratory, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France.
Medical Intensive Care Unit, Raymond Poincaré Teaching Hospital, 104 boulevard Raymond Poincaré, 92380, Garches, France.
Ann Intensive Care. 2020 Sep 30;10(1):128. doi: 10.1186/s13613-020-00742-z.
About 30% of patients with Guillain-Barré syndrome become ventilator dependent, of whom roughly 75% develop pneumonia. This trial aimed at assessing the impact of early mechanical ventilation (EMV) on pneumonia occurrence in GBS patients. We hypothesize that EMV will reduce the incidence of pneumonia.
This was a single centre, open-label, randomized controlled trial performed on two parallel groups. 50 intensive care unit adults admitted for Guillain-Barré syndrome and at risk for acute respiratory failure. Patients were randomized to early mechanical ventilation via face-mask or endotracheal intubation owing to the presence or absence of impaired swallowing (experimental arm), or to conventional care (control arm). The primary outcome was the incidence of pneumonia up to intensive care unit discharge (or 90 days, pending of which occurred first).
Twenty-five patients were randomized in each group. There was no significant difference between groups for the incidence of pneumonia (10/25 (40%) vs 9/25 (36%), P = 1). There was no significant difference between groups for the time to onset of pneumonia (P = 0.50, Gray test). During follow-up, there were 16/25 (64%) mechanically ventilated patients in the control group, and 25/25 (100%) in the experimental arm (P < 000·1). The time on ventilator was non-significantly shorter in the experimental arm (14 [7; 29] versus 21.5 [17.3; 35.5], P = 0.10). There were no significant differences between groups for length of hospital stay, neurological scores, the proportion of patients who needed tracheostomy, in-hospital death, or any serious adverse events.
In the present study including adults with Guillain-Barré syndrome at high risk of respiratory failure, we did not observe a prevention of pneumonia with early mechanical ventilation.
ClinicalTrials.gov under the number NCT00167622. Registered 9 September 2005, https://clinicaltrials.gov/ct2/show/NCT00167622?cond=Guillain-Barre+Syndrome&cntry=FR&draw=2&rank=1.
约30%的吉兰 - 巴雷综合征患者会出现呼吸依赖，其中约75%会发生肺炎。本试验旨在评估早期机械通气（EMV）对吉兰 - 巴雷综合征患者肺炎发生情况的影响。我们假设早期机械通气会降低肺炎的发生率。
这是一项在两个平行组上进行的单中心、开放标签、随机对照试验。50名因吉兰 - 巴雷综合征入住重症监护病房且有急性呼吸衰竭风险的成年人。根据是否存在吞咽功能障碍，患者被随机分为通过面罩或气管插管进行早期机械通气组（试验组）或常规护理组（对照组）。主要结局是直至重症监护病房出院（或90天，以先到者为准）时的肺炎发生率。
每组25名患者被随机分组。两组之间肺炎发生率无显著差异（10/25（40%）对9/25（36%），P = 1）。两组之间肺炎发病时间无显著差异（P = 0.50，Gray检验）。在随访期间，对照组有16/25（64%）的患者接受机械通气，试验组为25/25（100%）（P < 0.001）。试验组的机械通气时间略短但无显著差异（14 [7; 29] 对21.5 [17.3; 35.5]，P = 0.10）。两组在住院时间、神经功能评分、需要气管切开术的患者比例、院内死亡或任何严重不良事件方面均无显著差异。
在本研究中，纳入有呼吸衰竭高风险的吉兰 - 巴雷综合征成年患者，我们未观察到早期机械通气可预防肺炎。
ClinicalTrials.gov，编号NCT00167622。于2005年9月9日注册，https://clinicaltrials.gov/ct2/show/NCT00167622?cond=Guillain-Barre+Syndrome&cntry=FR&draw=2&rank=1。
