Airway management in out of hospital cardiac arrest patients.

Conditions

Out of hospital cardiac arrest (OHCA) Circulatory System Cardiac arrest

Jonathan R Benger, Kim Kirby, Sarah Black, Stephen J Brett, Madeleine Clout et al. (18 authors)

Health Technology Assessment2022-04-0118 citations

Cost-effectiveness of the i-gel supraglottic airway device compared to tracheal intubation during out-of-hospital cardiac arrest: Findings from the AIRWAYS-2 randomised controlled trial.

Stokes EA, Lazaroo MJ, Clout M, Brett SJ, Black S, Kirby K, Nolan JP, Reeves BC, Robinson M, Rogers CA, Scott LJ, Smartt H, South A, Taylor J, Thomas M, Voss S, Benger JR, Wordsworth S.

2021-06-116 citations

10.1016/j.resuscitation.2021.06.002

Design and implementation of a large and complex trial in emergency medical services

Maria Robinson, Jodi Taylor, Stephen J. Brett, Jerry P. Nolan, Matthew Thomas et al. (10 authors)

Trials2019-02-089 citations

10.1186/s13063-019-3203-0

Interventions

Control group: The current standard care pathway is tracheal intubation: the placement of a cuffed tube in the patient's trachea (windpipe) to provide oxygen to the lungs and remove ca

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The modified Rankin scale (mRS) score at hospital discharge, which incorporates survival to discharge and is widely used in OHCA research. Death scores 6, and mRS is usually presented dichotomously as good recovery (0-3) or poor recovery/death (4-6). We will collect survival and mRS at hospital discharge from routinely available clinical data with the prior permission of the Health Research Authority Confidentiality Advisory Group (CAG). However, other and longer-term outcomes are also important, and we will therefore seek consent from survivors (or a consultee according to the requirements of the Mental Capacity Act 2005 if the patient lacks capacity) to collect additional data at hospital discharge and 3 and 6 months after OHCA. We have chosen a 6-month final follow-up (compared to 3 in our feasibility study) because, whilst there are very few additional deaths between 3 and 6 months, cognitive function and quality of life continue to improve during this time.	—

Measure

Time frame

The modified Rankin scale (mRS) score at hospital discharge, which incorporates survival to discharge and is widely used in OHCA research. Death scores 6, and mRS is usually presented dichotomously as good recovery (0-3) or poor recovery/death (4-6). We will collect survival and mRS at hospital discharge from routinely available clinical data with the prior permission of the Health Research Authority Confidentiality Advisory Group (CAG). However, other and longer-term outcomes are also important, and we will therefore seek consent from survivors (or a consultee according to the requirements of the Mental Capacity Act 2005 if the patient lacks capacity) to collect additional data at hospital discharge and 3 and 6 months after OHCA. We have chosen a 6-month final follow-up (compared to 3 in our feasibility study) because, whilst there are very few additional deaths between 3 and 6 months, cognitive function and quality of life continue to improve during this time.

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Secondary

Measure	Time frame
We will seek consent from survivors (or a consultee according to the requirements of the Mental Capacity Act 2005 if the patient lacks capacity) to collect additional data at hospital discharge and 3 and 6 months after OHCA. All enrolled patients 1. Initial ventilation success, defined as visible chest rise. 2. Regurgitation/aspiration. 3. Loss of a previously established airway. 4. Actual sequence of airway interventions delivered. 5. Chest compression fraction. 6. Return of spontaneous circulation (ROSC). 7. Airway management in place when ROSC was achieved or the resuscitation was discontinued. 8. Economic data regarding expenditure and further healthcare contacts. Patients who survive to admission to hospital (estimated 20% of enrolled patients) 9. Length of intensive care stay. 10. Length of hospital stay. Patients who survive to hospital discharge (estimated 9% of enrolled patients) 11. Quality of life at hospital discharge. Patients who survive beyond hospital discharge (estimated 8% of enrolled patients) 12. Modified Rankin scale at 3 and 6 months following OHCA. 13. Quality of life (using the EQ5D) at 3 and 6 months following OHCA. 14. Cognitive function (using the cerebral performance category) 3 and 6 months following OHCA. 15. Date of death, where this occurs during the trial.	—

Measure

Time frame

We will seek consent from survivors (or a consultee according to the requirements of the Mental Capacity Act 2005 if the patient lacks capacity) to collect additional data at hospital discharge and 3 and 6 months after OHCA. All enrolled patients 1. Initial ventilation success, defined as visible chest rise. 2. Regurgitation/aspiration. 3. Loss of a previously established airway. 4. Actual sequence of airway interventions delivered. 5. Chest compression fraction. 6. Return of spontaneous circulation (ROSC). 7. Airway management in place when ROSC was achieved or the resuscitation was discontinued. 8. Economic data regarding expenditure and further healthcare contacts. Patients who survive to admission to hospital (estimated 20% of enrolled patients) 9. Length of intensive care stay. 10. Length of hospital stay. Patients who survive to hospital discharge (estimated 9% of enrolled patients) 11. Quality of life at hospital discharge. Patients who survive beyond hospital discharge (estimated 8% of enrolled patients) 12. Modified Rankin scale at 3 and 6 months following OHCA. 13. Quality of life (using the EQ5D) at 3 and 6 months following OHCA. 14. Cognitive function (using the cerebral performance category) 3 and 6 months following OHCA. 15. Date of death, where this occurs during the trial.

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Countries

England, United Kingdom

Outcome results

None listed