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The COOL study: A study of EnsoETM feasibility and safety

Study Abstract:

Background: Targeted temperature management (TTM) between 32 and 36 ◦C is recommended after outof-hospital cardiac arrest(OHCA).We aimed to assess the feasibility and safety ofthe “Esophageal Cooling Device” (ECD) in performing TTM. Patients and methods: This single-centre, prospective, interventional study included 17 comatose OHCA patients. Main exclusion criteria were: delay between OHCA and return of spontaneous circulation (ROSC) >60 min, delay between sustained ROSC and inclusion >360 min, known oesophageal disease. A TTM between 32 and 34 ◦C was performed using the ECD (Advanced Cooling Therapy, USA) connected to a heat exchanger console (Meditherm III® , Gaymar, France), without cold fluids’ use. Primary endpoint was feasibility of inducing, maintaining TTM, and rewarming using the ECD alone. Secondary endpoints were adverse events, focusing on potential digestive damages. Results were expressed as median (interquartiles 25–75). Results: Cooling rate to reach the Target Temperature (33 ◦C-TT) was 0.26 ◦C/h [0.19-0.36]. All patients reached the 32–34 ◦C range with a time spent within the range of 26 h [21–28] (3 patients did not reach 33 ◦C). Temperature deviation outside the TT during TTM-maintenance was 0.10 ◦C [0.03–0.20]. Time with deviation >1 ◦C was 0 h. Rewarming rate was 0.20 ◦C/h [0.18–0.22]. Among the 16 gastrointestinal endoscopy procedures performed, 10 (62.5%) were normal. Minor oeso-gastric injuries (37.5% and 19%, respectively) were similar to usual orogastric tube injuries. One patient experienced severe oesophagitis mimicking peptic lesions, not cooling-related. No patient among the 9 alive at 3-month follow-up had gastrointestinal complains. Conclusion: ECD seems an interesting, safe, accurate, semi-invasive cooling method in OHCA patients treated with 33 ◦C-TTM, particularly during the maintenance phase.