Cardiopulmonary Effects of Prone Position in CARDS

Completed

• Conditions: ARDS Due to Disease Caused by SARS Co-V-2; Right Ventricular Dysfunction
• Interventions: Procedure: before prone position; Procedure: the first hour of prone position; Procedure: the first hour of returning to the supine position

• Registration Number: NCT06456606
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

In coronavirus disease-2019 (COVID-19)-related ARDS (C-ARDS), especially in the severe form, increased shunt rate, impaired ventilation/perfusion ratio (V/Q), hypoxic pulmonary vasoconstriction inhibition, and increased immune microthrombosis may have similar effects on the right ventricle .The cardiopulmonary pathophysiology and outcomes of C-ARDS vary, and this variability requires monitoring to follow the diagnosis and treatment process. This study aimed to increase the treatment success of the prone position in C-ARDS and to provide a prognostic factor for survival by analyzing and monitoring heart-lung interactions. Therefore, we used transesophageal echocardiography (TEE) to evaluate the cardiopulmonary effects of prone position.

Detailed Description

This prospective study included 30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (PP) (T0), the first hour of PP (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment. Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) was preferred right ventricular evaluations as primer outcome. Static compliance (C-stat) was examined in the evaluation of the pulmonary effect of prone position as secondary outcome.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-04-10
• Study Completion: 2022-05-30
• Study First Submitted: 2024-05-31
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• >18 years
• Patients diagnosed with polymerase chain reaction/computed tomography results
• Moderate/severe severity class according to the Berlin ARDS classification
• Prone position applied in the first 48 h after orotracheal intubation in treatment
• Obtaining an informed consent form

Exclusion Criteria

• Pulmonary embolism
• Pneumothorax
• Heart valve disease
• Pregnancy
• Perforated esophageal varices
• Coagulopathy
• Esophageal stricture
• Esophageal tumor
• Neck fracture
• Thrombocytopenia
• Gastrointestinal bleeding
• Previous stomach surgery
• Previous esophageal surgery
• Esophageal perforation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group a	the first hour of returning to the supine position	30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment.
group a	before prone position	30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment.
group a	the first hour of prone position	30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment.

Primary Outcome Measures

Name	Time	Method
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) change during prone position.	It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment	It was preferred right ventricular recovery evaluation.

Secondary Outcome Measures

Name	Time	Method
Static compliance (C-stat) change with prone position	It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment	It was examined in the evaluation of the pulmonary effect of prone position as secondary outcome.

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Research Hospital; 🇹🇷 Istanbul, Bakırköy, Turkey