Related Experiment Videos

Protocolized Evaluation of Permissive Blood Pressure Targets Versus Usual Care (PRESSURE): Statistical Analysis Plan

Tommaso Viola1, Julia Broomhall1, Zia Sadique2

  • 1Clinical Trials Unit, Intensive Care National Audit and Research Centre (ICNARC), London, United Kingdom.

Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
|May 7, 2026
PubMed

Insights

This study outlines the analysis plan for the PRESSURE trial, comparing permissive mean arterial pressure (MAP) targets with usual care in critically ill children. The trial will assess outcomes like mortality and ventilation duration to guide pediatric critical care strategies.

Area of Science:

  • Pediatric Critical Care Medicine
  • Hemodynamic Management
  • Clinical Trial Design

Background:

  • Hypotension in critically ill children often requires vasoactive drugs and mechanical ventilation.
  • Establishing optimal blood pressure targets is crucial for improving outcomes in pediatric intensive care units (PICUs).
  • The Protocolized Evaluation of Permissive Blood Pressure Targets vs. Usual Care (PRESSURE) trial addresses this clinical uncertainty.

Purpose of the Study:

  • To detail the prespecified analysis plan for the PRESSURE randomized controlled trial.
  • To compare a permissive mean arterial pressure (MAP) target strategy with usual care in critically ill children.
  • To evaluate the impact of different MAP targets on mortality, duration of mechanical ventilation, and other key outcomes.

Main Methods:

  • A pragmatic, open-label, multicenter, parallel-group randomized controlled trial with an integrated economic evaluation.
  • Inclusion criteria: Critically ill infants and children (older than 38 weeks corrected gestational age) up to 16 years, on invasive mechanical ventilation (IMV) and receiving vasoactive drugs.
  • Intervention: Adjustment of hemodynamic support to achieve a permissive MAP target greater than the age-specific fifth centile during IMV.

Main Results:

  • Primary outcome: Composite of 30-day mortality and duration of IMV, analyzed using a two-sample rank-sum test.
  • Secondary outcomes: Mortality at various time points, survival duration, time to liberation from IMV, functional status, renal replacement therapy, and length of stay.
  • Health economic analysis: Intention-to-treat principle, reporting incremental costs, quality-adjusted life years, and cost-effectiveness up to 12 months.

Conclusions:

  • The results of the PRESSURE trial will be disseminated through peer-reviewed publications and conference presentations.
  • This analysis plan ensures rigorous evaluation of a permissive MAP strategy in pediatric critical care.
  • Findings will inform clinical practice guidelines for managing hypotension in critically ill children.
Abstract

Keywords:
health economicsmean arterial pressurepediatric intensive carerandomized clinical trialstatistical analysis planvasopressor

Related Concept Videos

Pre-Procedural Guidelines for Assessing Blood Pressure01:10

Pre-Procedural Guidelines for Assessing Blood Pressure

Accurate blood pressure assessment is crucial for diagnosing and managing various health conditions. To ensure the reliability of these measurements, healthcare professionals must adhere to standardized pre-procedural guidelines. These guidelines enhance patient safety and improve the overall quality of healthcare. The following steps are essential for obtaining accurate and consistent blood pressure readings, from using the appropriate tools to ensuring effective communication with the patient.
Measurement of Blood Pressure01:17

Measurement of Blood Pressure

Assessing blood pressure is a standard procedure executed in virtually all medical environments. The method utilized today was established over a hundred years ago by an innovative Russian doctor, Dr. Nikolai Korotkoff. The soft ticking noise, known as Korotkoff sounds, heard while taking blood pressure readings results from turbulent blood flow within the vessels. The apparatus required for this procedure includes a sphygmomanometer, a blood pressure cuff attached to a gauge, and a stethoscope.
Errors occurring during blood pressure monitoring01:25

Errors occurring during blood pressure monitoring

Blood pressure monitoring is a crucial clinical procedure in diagnosing and managing various cardiovascular conditions. Despite its significance, the accuracy of blood pressure measurements can be compromised by multiple factors, potentially leading to either falsely high or low readings. These inaccuracies are critical as they can significantly impact patient care. So, it is vital to understand these challenges deeply and adopt strategic approaches to minimize errors.
Several factors...
Hypertension III: Clinical Manifestations and Diagnostic Studies01:30

Hypertension III: Clinical Manifestations and Diagnostic Studies

Hypertension is asymptomatic and also referred to as the "silent killer" until it progresses to a severe stage or causes target organ disease. Patients may experience symptoms stemming from the strain on blood vessels and tissues in various organs or the heart's increased workload.Physical exams might show no abnormalities other than high blood pressure. Signs of vascular damage, when present, correspond to the organs supplied by the affected vessels, leading to target organ damage. For...
Sites for measuring blood pressure01:21

Sites for measuring blood pressure

Blood pressure measurement is a fundamental clinical procedure, providing crucial data for assessing cardiovascular health. Among the various sites for this measurement, the brachial and popliteal arteries are predominantly utilized due to their accessibility and the reliability of their readings. This lesson delves into the anatomical significance, methodology, and considerations of measuring blood pressure at these locations.
The Brachial Artery: Primary Site for Blood Pressure Measurement
Special considerations while measuring blood pressure01:28

Special considerations while measuring blood pressure

When assessing blood pressure (BP), healthcare professionals must consider various factors and potential unexpected outcomes to ensure accurate readings and provide proper patient care. Adhering to these guidelines is essential to achieving the most reliable results.
Monitoring Both Arms:
Monitoring BP in both arms during the initial assessment is advisable, as the systolic value may differ by five to ten mm Hg between arms. For subsequent BP assessments, use the arm with the higher reading.