About PRINCESS 2
PRINCESS 2 is an investigator initiated randomized trial. It’s a sequel to the previous PRINCE and PRINCESS trials. The overall aim with the study is to investigate if early therapeutic hypothermia started already prehospital can be beneficial for cardiac arrest patients in terms of survival with complete neurologic recovery.
The trial is led by Principal investigators Dr. Per Nordberg, associate professor and senior consultant in cardiology and intensive care at Karolinska University Hospital, Stockholm, Sweden and Dr. Fabio Taccone, assistant professor and director of the neuro ICU at Erasme Hospital, Brussels, Belgium.
The method used is transnasal evaporative cooling with the Rhinocill™ device. The device is portable and carried in the ambulance to the scene of the cardiac arrest. As soon as an airway is secured the cooling can take place. A special nasal catheter is inserted in the patient’s nostrils. The catheter has spray ports aimed cranial against the nasal cavity. The liquid coolant is sprayed with air or oxygen and instantly starts cooling of the patient. You can read more about the device on .
The method has been tested in several trials for feasibility and also in trials with survival endpoint. It has shown a benefit primarily in patients where the cooling is started within 20 minutes and where the patient has a shockable rhythm. This is the group of patients that the PRINCESS 2 is aimed to study.
The trial is a multicenter RCT and is planned to recruit around 1000 patients in total. The intervention arm will get the treatment with early hypothermia and the control arm will be treated as standard today. The complete study protocol can be found under Documents and support.
Publications
Nordberg P, Taccone FS, Truhlar A, Forsberg S, Hollenberg J, Jonsson M, Cuny J, Goldstein P, Vermeersch N, Higuet A, Jiménes FC, Ortiz FR, Williams J, Desruelles D, Creteur J, Dillenbeck E, Busche C, Busch HJ, Ringh M, Konrad D, Peterson J, Vincent JL, Svensson L
JAMA 2019 May;321(17):1677-1685
Awad A, Taccone FS, Jonsson M, Forsberg S, Hollenberg J, Truhlar A, Ringh M, Abella BS, Becker LB, Vincent JL, Svensson L, Nordberg P
Intensive Care Med 2020 Jul;46(7):1361-1370
Taccone FS, Hollenberg J, Forsberg S, Truhlar A, Jonsson M, Annoni F, Gryth D, Ringh M, Cuny J, Busch HJ, Vincent JL, Svensson L, Nordberg P, ,
Crit Care 2021 Jun;25(1):198
Castrén M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guérisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D
Circulation 2010 Aug;122(7):729-36
Busch HJ, Eichwede F, Födisch M, Taccone FS, Wöbker G, Schwab T, Hopf HB, Tonner P, Hachimi-Idrissi S, Martens P, Fritz H, Bode Ch, Vincent JL, Inderbitzen B, Barbut D, Sterz F, Janata A
Resuscitation 2010 Aug;81(8):943-9
Tjerkaski J, Hermansson T, Dillenbeck E, Taccone FS, Truhlar A, Forsberg S, Hollenberg J, Ringh M, Jonsson M, Svensson L, Nordberg P
J Clin Med 2022 Oct;11(21):
Macchini E, Dillenbeck E, Jonsson M, Annoni F, Forsberg S, Hollenberg J, Truhlar A, Svensson L, Nordberg P, Taccone FS
Brain Sci 2022 Oct;12(10):