Prone Position With Different Types of Cushions in Patients With ARDS

NCT06184490 | Unknown DMC

• 1 other identifier: 2022-0323
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Prone Position; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Lung recruitment

  Change in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography

  1 hour before prone - 2 hours before supine

Study Arms (2)

Usual prone position

NO INTERVENTION

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

Modified prone position

EXPERIMENTAL

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

Procedure: Prone position with thoraco-abdominal cushion

Interventions

Prone position with thoraco-abdominal cushion PROCEDURE

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

Modified prone position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vanessa Martins de de Oliveira

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Martins de de Oliveira

CONTACT

+55519992513723; vmoliveira@hcpa.edu.br

Mariana Berger do Rosário

CONTACT

+5554999508966; mrosario@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: August 15, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)