Chapter 3 Methods

3.1 Study design and participants

This randomised controlled trial was conducted in Yorkshire Ambulance Service NHS Trust (YAS) between August and December, 2018. Participants were NHS staff employed by YAS, who were Health and Care Professions Council (HCPC) registered paramedics at the time of enrolment in the study, authorised to intubate and who had received no SALAD training in the previous three months. Potential participants were excluded if they did not meet the inclusion criteria, were allergic to the ‘vomit’ ingredients or unwilling to provide consent to participate.

3.2 Randomisation

In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into either: making two pre-training intubation attempts and one post-training attempt (group AAB); or making one pre-training intubation attempt and two post-training attempts (ABB). Groups were evenly allocated (i.e. 1:1) using a block randomisation sequence provided by RANDOM.ORG. To distinguish between the training pathways and number of the assessed attempts, group AAB’s attempts were denoted A01A02B01 and group ABBs, A11B11B12. It was not possible to blind participants or the researcher from the group allocation.

3.3 Intervention

3.3.1 SALAD manikin

A modified TruCorp AirSim Advance airway manikin was used for the study as it has realistic airway anatomy and can be used for tracheal intubation training (Yang et al. 2010). The oesophagus of this manikin was connected, via a hosepipe, to a bilge pump sited within a reservoir of simulated vomit (Figure 3.1). The vomit was water, coloured with food-grade colouring, and thickened with xanthan gum (a food additive). While there are recipes for solid-containing vomit, it was decided that as a first introduction to the technique, thickened opaque vomit would present a sufficient challenge. Once the bilge pump was switched on, a constant flow of vomit was propelled into the oropharynx, obscuring any view of the laryngeal inlet. The flow rate was controlled by a tap, which was calibrated to provide 1 L/min of vomit to the oropharynx of the manikin during intubation attempts. To keep vomit within the oropharynx, the left and right bronchi on the manikin were occluded.

Standard intubation equipment, including personal protective equipment (PPE) and motorised suction routinely used within YAS, was provided for participants, and the study researcher acted as a competent assistant for the intubation attempts.

SALAD manikin setup used for the study

Figure 3.1: SALAD manikin setup used for the study

3.3.2 Procedure

Once informed consent was obtained, paramedics were randomised into either group AAB or ABB. All attempts utilised direct laryngoscopy, which is the standard intubation technique within YAS. Prior to each intubation attempt, the manikin was primed with vomit to ensure the same level of oropharyngeal obstruction. All attempts were video recorded for timing accuracy.

Participants were deemed to have commenced their attempt once the bilge pump was turned on. The attempt was considered to be over when either: the paramedic intubated the manikin and verbally confirmed with the researcher that the attempt had been completed or; 90 seconds had elapsed or; the tracheal tube was placed into the oesophagus and the cuff inflated while the pump was still running.

If the tracheal tube was not in the trachea, with the cuff inflated and connected to a bag-valve device within 90 seconds, the attempt was considered a failure. While it is generally advocated that intubation attempts should take no longer than 30 seconds, this assumes that it is possible to pre-oxygenate patients before an intubation attempt, and re-oxygenate them in the event that intubation is not possible. In patients who have an oropharynx full of vomit, oxygenation is not possible. Therefore a pragmatic and prolonged target of 90 seconds was suggested by Dr. DuCanto (J.DuCanto, personal communication, April 26, 2018).

Participants randomised into the two pre-training attempts group (AAB) made their second intubation attempt immediately following the first, and prior to the group training session. Once all participants completed their pre-training intubation attempt(s), the training session was delivered. The training intervention adopted the Advanced Life Support Group/Resuscitation Council 4-stage approach of skills teaching, comprising (Bullock et al. 2008):

  1. A real-time demonstration of the SALAD technique by the researcher
  2. A repeated demonstration with an explanation of the rationale of the steps taken when performing SALAD (not real-time)
  3. Another demonstration of the SALAD technique conducted by the researcher, but guided by one of the participants
  4. An attempt by the same participant who guided the researcher in the previous step, followed by a practice attempt by the other participants.

Following the training session, participants made their post-training intubation attempt(s) conducted using the same method as for the pre-training intubation attempt(s). Participants randomised into the two post-training attempts (ABB), made their second attempt immediately following the first post-training attempt.

3.4 Outcomes

The primary outcome was the difference in proportions of paramedic first-pass intubation success rates, before and after SALAD training.

The secondary outcomes were:

  • Mean of the differences between groups AAB and ABB with respect to the first and second successful intubation attempt times, and between the first and third successful intubation attempt times, in order to detect improvements in time to successful intubation
  • Difference in success rates between participants who have two post-training intubation attempts (ABB) versus participants who only have one post-training intubation attempt (AAB).

3.5 Statistical analysis

3.6 Sample size

A sample size of 154 participants was calculated to be required to detect a change in the proportion of intubation successes, from 0.25 in the pre-training group, to 0.50 in post-training group, with a power (1-\(\beta\)) of 90% and a significance level (\(\alpha\)) of 5%. Given that there is no literature to guide expected performance, a conservative estimate was made in consultation with an internationally recognised SALAD expert, Dr. James DuCanto (J.DuCanto, personal communication, April 26, 2018).

3.6.1 Primary outcome analysis

To determine if the training had an effect and increased the success rate of intubation, the proportions of success in the groups who received no training before their 2nd intubation attempt (A02) was compared to those who did receive training before their 2nd intubation attempt (B11). Comparing the rates at these time points, controlled for any learning effect due to participants making more than one attempt at intubation. The difference in the two proportions was analysed using a two independent samples proportion z-test, assuming a two-sided type 1 error rate of 5%.

3.6.2 Secondary outcome analysis

Only successful intubation attempts and their timings were included in the secondary outcome analysis. It was hypothesised that time to successful intubation might improve as a result of repeated attempts at intubation i.e. be due to a practice effect, rather than the SALAD technique alone. Therefore, the mean of the attempt time differences (A01 – A02) were compared with the mean of attempt time differences (A11 – B11). In addition, the mean of the attempt time differences seen at the final measurements, (A01 – B01) were compared to the mean of the attempt time differences (A11 – B12). Finally, success rates between B01 and B12 attempts were compared to see whether practice following training improved the intubation success rate. A Student’s t-test was utilised to test for the differences between mean pre- and post-training intubation attempt times, and a two independent samples proportion z-test to test the difference in success rates.

References

Yang, J H, Y-M Kim, H S Chung, J Cho, H-M Lee, G-H Kang, E-C Kim, T Lim, and Y S Cho. 2010. “Comparison of Four Manikins and Fresh Frozen Cadaver Models for Direct Laryngoscopic Orotracheal Intubation Training.” Emergency Medicine Journal 27 (1): 13–16. https://doi.org/10.1136/emj.2008.066456.

Bullock, Ian, Mike Davis, Andrew Lockey, and Kevin Mackway-Jones. 2008. Pocket Guide to Teaching for Medical Instructors. 2nd ed. Malden: BMJ Books.