Trial Outcomes & Findings for Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics (NCT NCT03599687)

NCT ID: NCT03599687

Last Updated: 2020-08-13

Results Overview

This measure is a comparison of Group AAB's first-pass intubation success rate, using an attempt which occurred before SALAD training, and Group ABB's intubation success rate, using an intubation attempt that occurred after SALAD training.

• Recruitment status: COMPLETED
• Target enrollment: 164 participants
• Primary outcome timeframe: pre- and post-training as part of 2 hour study session
• Results posted on: 2020-08-13

Participant Flow

Participant milestones

Measure	Group AAB 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 one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.	Group ABB Participants randomised into making one pre-training and two post-training intubation attempts.
Overall Study STARTED	82	82
Overall Study COMPLETED	82	82
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group AAB n=82 Participants 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 one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.	Group ABB n=82 Participants Participants randomised into making one pre-training and two post-training intubation attempts.	Total n=164 Participants Total of all reporting groups
Age, Customized Adults > 18 years	82 Participants n=82 Participants	82 Participants n=82 Participants	164 Participants n=164 Participants
Sex/Gender, Customized Gender Unknown	82 Participants n=82 Participants	82 Participants n=82 Participants	164 Participants n=164 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	82 participants n=82 Participants	82 participants n=82 Participants	164 participants n=164 Participants
Intubation attempts in past 12 months	2.5 attempts n=82 Participants	3.0 attempts n=82 Participants	3.0 attempts n=164 Participants
Successful intubation attempts in past 12 months	2 attempts n=82 Participants	2 attempts n=82 Participants	2 attempts n=164 Participants
Years as a paramedic	5 years n=82 Participants	3.5 years n=82 Participants	4 years n=164 Participants
Awareness of SALAD technique	15 Participants n=82 Participants	21 Participants n=82 Participants	36 Participants n=164 Participants

PRIMARY outcome

Timeframe: pre- and post-training as part of 2 hour study session

This measure is a comparison of Group AAB's first-pass intubation success rate, using an attempt which occurred before SALAD training, and Group ABB's intubation success rate, using an intubation attempt that occurred after SALAD training.

Outcome measures

Measure	Group AAB n=82 Participants 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 one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.	Group ABB n=82 Participants Participants randomised into making one pre-training and two post-training intubation attempts.
Difference in First-pass Intubation Success Rates Before and After SALAD Training	44 Participants	74 Participants

SECONDARY outcome

Timeframe: seconds

Outcome measures

Measure	Group AAB n=23 Participants 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 one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.	Group ABB n=28 Participants Participants randomised into making one pre-training and two post-training intubation attempts.
Difference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart.	15.4 seconds Standard Error 3.5	3.7 seconds Standard Error 3.4

SECONDARY outcome

Timeframe: pre- and post-training as part of 2 hour study session

Outcome measures

Measure	Group AAB n=82 Participants 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 one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts.	Group ABB n=82 Participants Participants randomised into making one pre-training and two post-training intubation attempts.
Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt	71 Participants	73 Participants

Adverse Events

Group AAB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group ABB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Pilbery

Yorkshire Ambulance Service NHS Trust

Phone: +447463734823

Email: r.pilbery@nhs.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place