Clinical trial NCT06184490: Prone Position With Different Types of Cushions in Patients With ARDS
Official title: Prone Position With Different Types of Cushions in Patients With Acute Respiratory Distress Syndrome - Effects on Mechanics, Oxygenation, and Electrical Impedance Tomography Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prone Position
Acute Respiratory Distress Syndrome
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prone maneuver is a well-established therapy in ARDS. Traditionally, the maneuver is perform with thoraco-abdominal cushions. The goal of this study is assess, using electrical impedance tomography, whether the arrangement mode of the cushions alters lung recruitment during the prone maneuver in patients with moderate to severe ARDS.

Detailed description: The prone position is a ventilatory therapeutic strategy used in the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) that promotes improved oxygenation with consequent reduction in mortality. Despite being safe and effective, it is not without complications, with pressure injuries being one of the main concerns. The use of cushions helps prevent such injuries, but they can interfere with ventilatory mechanics depending on where they are placed. The aim of this study is to assess whether there is a difference in ventilatory mechanics when performing the prone maneuver with a thoraco-abdominal cushion or a modified lateral cushion, based on measurements from electrical impedance tomography (EIT), gasometric data, and parameters of mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years or more, with
* moderate or severe acute respiratory distress syndrome (ARDS), and
* indication of prone position

Exclusion Criteria:

* Contra-indication to the prone position: intracranial pressure \> 30 mmHg or cerebral perfusion pressure \< 60 mmHg; massive haemoptysis needing urgent surgical or radiological treatment; tracheal or thoracic surgery in the last 15 days; facial trauma or surgery in the last 15 days; deep venous thrombosis or pulmonary embolism treated in the last 2 days; unstable bone dislocations of rachis, femur, rib cage, pelvis; mean systolic arterial pressure less than 70 mmHg despite vasopressive therapy and pregnancy
* Severe acute respiratory distress syndrome (ARDS) caused b coronavirus disease 2019 (despite meeting the Berlin criteria for ARDS, their ventilatory mechanics are characterized by nearly normal compliance, something rarely seen in patients with ARDS from other etiologies)
* contraindications for the use of Electrical Impedance Tomography (EIT) such as presence of a cardiac implantable electronic device
* Pulmonary transplantation
* Prone position before enrollment

Primary outcomes:
measure: Lung recruitment
timeFrame: 1 hour before prone - 2 hours before supine
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Vanessa Martins de de Oliveira
role: PRINCIPAL_INVESTIGATOR
References: