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. 2020 Sep 18;10(9):e036671. doi: 10.1136/bmjopen-2019-036671

Table 1.

Standard Protocol Items: Recommendations for Interventional Trials checklist

Timepoint Study period
Enrolment Allocation On-study On-study
Decision to perform TI Between decision to intubate and Induction Sedative and NMB TI 2 min post-TI 1 1 hour post TI 24 hours post-TI Discharge or 28 days after enrolment
Enrolment X
Eligibility screen X
Allocation X
Interventions
Fluid bolus initiation X
Screening for contraindications X X
No new fluid bolus X
Screening for contraindications X X
Assessments
Baseline variables X X
Peri-procedural variables X X X X
Clinical outcomes X X X

Baseline variables obtained from medical record include: demographic characteristics, Acute Physiology and Chronic Health Evaluation II (APACHE II) score and presence of sepsis/septic shock. Peri-procedural data collected by independent, trained observer includes the following: whether fluids were infusing prior to enrolment, receipt of the study intervention, the volume of study crystalloid infused (induction and 2 min after procedure), use of prophylactic vasopressor (or prophylactically increased vasopressor dose), addition of new vasopressor (or increased vasopressor dose) and systolic blood pressure (at baseline and nadir from induction to 2 min after procedure). Peri-procedural data collected by operator includes: sedation drugs used (and doses), oxygenation/ventilation modality between induction and laryngoscopy, and procedural complications. Clinical outcomes include: vital status (overall in-hospital death, cardiac arrest death within 1 hour of TI), number of ventilator-free days to 28 days, and number of intensive care unit-free days to 28 days.

NMB, neuromuscular blockade; TI, tracheal intubation.