Prone Position With Different Types of Cushions in Patients With ARDS

NCT ID: NCT06184490

Last Updated: 2023-12-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2025-12-31

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.

Conditions

Prone Position; Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual prone position

Prone position with thoraco-abdominal support (cushions on the chest and hips, leaving the abdomen free)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Modified prone position

Prone position with lateral support (lateral cushions on the chest, hips and abdomen)

Group Type: EXPERIMENTAL

Prone position with thoraco-abdominal cushion

Intervention Type: PROCEDURE

Prone position with cushions positioned laterally on the chest, abdomen, and pelvis

Interventions

Prone position with thoraco-abdominal cushion

Prone position with cushions positioned laterally on the chest, abdomen, and pelvis

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Martins de de Oliveira

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Vanessa Martins de de Oliveira

Role: CONTACT

Phone: +55519992513723

Email: vmoliveira@hcpa.edu.br

Mariana Berger do Rosário

Role: CONTACT

Phone: +5554999508966

Email: mrosario@hcpa.edu.br

Facility Contacts

Vanessa Martins de Oliveira

Role: primary

Other Identifiers

2022-0323

Identifier Type: -

Identifier Source: org_study_id