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Completed

NCT Number: NCT06456606

Cardiopulmonary Effects of Prone Position in CARDS

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.

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Key information

Conditions

ARDS Due to Disease Caused by SARS Co-V-2 Cardiovascular Diseases Heart Diseases Right Ventricular Dysfunction Ventricular Dysfunction Ventricular Dysfunction, Right

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakirkoy Dr. Sadi Konuk Research Hospital

Istanbul, Bakırköy, 34140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

before prone position

Procedure

It was evaluated with transesophageal echocardiography

Other names: t0

the first hour of prone position

Procedure

It was evaluated with transesophageal echocardiography

Other names: t1

the first hour of returning to the supine position

Procedure

It was evaluated with transesophageal echocardiography

Other names: t2

Primary outcomes

  1. Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) change during prone position.

    Time frame: 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 outcomes

  1. Static compliance (C-stat) change with prone position

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

The Effect of Prone Position on Right Ventricular Functions in CARDS: is Survival Predictable When Evaluated Through Transesophageal Echocardiography?

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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