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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06184490
Other study ID # 2022-0323
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2023
Est. completion date December 2025

Study information

Verified date December 2023
Source Hospital de Clinicas de Porto Alegre
Contact Vanessa Martins de de Oliveira
Phone +55519992513723
Email vmoliveira@hcpa.edu.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Prone position with thoraco-abdominal cushion
Prone position with cushions positioned laterally on the chest, abdomen, and pelvis

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lung recruitment Change in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography 1 hour before prone - 2 hours before supine
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