Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06819943

Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between The Patient And The Support Surface

Led by University of Sao Paulo General Hospital · Updated on 2025-06-22

25

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pressure injuries occur when sustained pressure damages the skin and underlying tissues, commonly affecting critically ill patients. This research evaluates the use of automated lateral rotation therapy to reduce pressure between the patient and their support surface, aiming to prevent these injuries. The study also looks at how different head-of-bed elevations impact pressure, respiratory function, heart stability, and gastroesophageal safety in mechanically ventilated patients. Participants will experience automated lateral tilting using a special bed system that can tilt up to 30 degrees sideways. The study compares two lateral tilt angles, 15 and 30 degrees, combined with head-of-bed elevations of 10 and 30 degrees, against a standard supine position with a 30-degree elevation. Each position is held for 10 minutes with washout periods in between, and a subgroup will have longer monitoring at 30 degrees lateral tilt to observe pressure changes over two hours. Advanced monitoring devices track pressure, lung function, blood flow, and esophageal pH during the interventions. Throughout the study, patients will be closely monitored using sensors embedded in the mattress, electrical impedance tomography for lung ventilation, continuous cardiac output measurement, and esophageal pH probes. Researchers will measure peak and mean pressure at key body areas and assess respiratory and cardiovascular parameters along with gastric pH changes. Safety events like low blood pressure or reflux will be recorded. The total participation involves multiple position changes and monitoring sequences in an ICU setting to evaluate the effectiveness and safety of this therapy in preventing pressure injuries.

CONDITIONS

Brief Title

Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between The Patient And The Support Surface

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult and elderly patients aged 18 years or older
  • Patients under controlled or assisted mechanical ventilation who are not yet eligible for weaning
Not Eligible

You will not qualify if you...

  • Need for norepinephrine greater than 0.3 mcg/kg/min or mean arterial pressure below 60 mmHg despite vasopressors
  • Cardiac arrhythmias or bleeding causing hemodynamic instability
  • Neurological diseases or symptoms
  • Spinal cord injury such as paraplegia
  • Dependence on a cardiac pacemaker
  • Contraindications to hypercapnia like intracranial hypertension or acute coronary syndrome
  • Air leakage from chest drains, pneumothorax, or undrained subcutaneous emphysema
  • Existing pressure injuries in bony areas (sacral, occipital, scapular, or calcaneal) at admission
  • Medical refusal to include the patient in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 1 day per participant

Participants undergo automated lateral rotation therapy using a platform-based lateral tilt system integrated into the Linet Multicare bed. The therapy includes lateral tilting at 15 and 30 degrees combined with head-of-bed elevation at 10 or 30 degrees. Each position is maintained for 10 minutes, separated by a 10-minute washout period in the supine position. Positions are performed on both sides according to randomization, with sequences repeated for two different head-of-bed elevations. Monitoring of interface pressure, respiratory, hemodynamic, and gastroesophageal parameters occurs throughout the protocol.

1 in-person treatment session with multiple position changes and continuous monitoring

Post-treatment Extended Monitoring

Duration - 4 hours total

A subgroup of participants undergo extended monitoring where the lateralized position at 30 degrees with a 30-degree head-of-bed elevation is maintained for 2 continuous hours on each side to assess the temporal evolution of interface pressure over time.

1 extended monitoring session (in-person)

Trial Site Locations

Total: 1 location

1

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo

São Paulo, São Paulo, Brazil, 05403-900

Actively Recruiting

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Research Team

M

Marcelo BP Amato, MD PhD

A

Anne C Almeida de Sousa, PT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

1

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