Hachimi‐Idrissi 2005 SSP.
Study characteristics | |
Methods | Study type: RCT Aim of the study: efficacy Participating sites: 1 university hospital in Brussels, Belgium Language: English Start date, end date: October 1999 to June 2002 |
Participants | Number randomised: 16 (intervention); 17 (control) Inclusion criteria: asystole or PEA, aged > 18 years, tympanic temperature > 30 °C, GCS < 7 Exclusion criteria: cardiac arrest resulting from intoxication or trauma, responding to verbal command after ROSC, tympanic temperature < 30 °C at admission, evidence of hypotension (mean arterial pressure < 60 mmHg for > 30 minutes on admission), terminal illness, pre‐existing coagulopathy, pregnancy, unavailable for follow‐up Mean age: 72.5 (SD 3) years (intervention); 74.1 (SD 2) years (control) Women: 36% Cardiac arrest location: out‐of‐hospital Cause of cardiac arrest: not specified Primary cardiac rhythm:
Witnessed cardiac arrest: 55% Bystander CPR: 15% Timing cardiac arrest (out‐of‐hospital cardiac arrest) (minutes):
Temperature on admission/at start of cooling: n.i. Subgroups reported: none |
Interventions | Means of cooling: helmet device (Frigicap including an aqueous glycerol solution) Cooling rate: n.i. Target temperature: 33 °C Duration of cooling: until target temperature of 33 °C was reached (was expected within 4 hours) Was intervention started within 2 hours after ROSC? n.i. Was target temperature reached within 4 hours of ROSC? n.i. Timing of intervention (minutes): n.i. Rewarming: 18 hours (1 °C every 4 hours) |
Outcomes | Good neurological outcome (CPC 1, 2) at 6 months Death at 6 months |
Control group treatment | Participants randomised to normothermia were allowed to rewarm‐up passively to 37 °C and then maintained at normothermia. |
Funding source | Mrs N Maes and the Byk Belga SA (Belgium) provided Sangtecs100 kits during the study. |
Notes | Hachimi‐Idrissi 2005 LSP and Hachimi‐Idrissi 2005 SSP were published in 1 report but they were 2 distinct study populations. |