Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest

South Western Ambulance Service NHS Foundation Trust (UK)0 个研究点目标入组 10,819 人开始时间: 2014年7月28日最近更新: 2022年5月2日

适应症

试验速览

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27697605 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30167701 results 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30736841 trial design and implementation 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32045662 participant interview results (added 12/02/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33010371/ 3- and 6-month follow-up results (added 16/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34126133/ cost-effectiveness results (added 15/06/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35426781/ (added 19/04/2022)

•Paramedic inclusion criteria:
•1. Employed by one of the four participating ambulance trusts in general operational duties, and could therefore be despatched to attend an OHCA as the first or second paramedic to arrive on scene.
•Patient inclusion criteria:
•1. Patient known or believed to be 18 years of age or older
•2. Must be in non-traumatic cardiac arrest outside hospital
•3. Patient must be attended by a paramedic who is participating in the trial and is either the 1st or 2nd paramedic to arrive at scene.*1
•4. Resuscitation is attempted by ambulance staff.*2
•*1 The time and order of staff arrival is routinely collected by ambulance services. The participating paramedic will manage the patient?s airway, according to their allocation. If both the 1st and 2nd paramedic are participating in the trial, the patient?s airway will be managed according to the allocation of the 1st paramedic to arrive (usually designated as the ?attendant? within the ambulance service).
•*2 Circumstances in which resuscitation should and should not be attempted are described in national guidelines, but the frequency of attempted resuscitation in both arms will be regularly examined by the DMSC to identify any bias in the commencement of resuscitation attempts

•Paramedic exclusion criteria:
•1. Paramedics working in non-clinical and managerial roles not routinely attending OHCA
•Patient exclusion criteria:
•1. Patient detained by Her Majesty's Prison Service
•2. Previously recruited to the trial
•3. Estimated weight <50 kg
•4. Mouth opening <2 cm
•The latter two exclusions have been applied because SADs are not designed for use in patients with low bodyweight or significantly reduced mouth opening. There is a risk of post-randomisation bias being introduced by these two exclusion criteria, but in our feasibility study only 2/711 patients (0.3%) were excluded on these grounds. We will monitor these exclusions, under the supervision of the DMSC, and should the exclusion rate exceed 1% we will take action to address this through enhanced training and supervision.

发起方

South Western Ambulance Service NHS Foundation Trust (UK)