Cardiopulmonary Effects of Prone Position in CARDS

Right Ventricular Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06456606
• Other study ID #: 2022/40
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2024
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2022
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Procedure:
• before prone position
It was evaluated with transesophageal echocardiography
• the first hour of prone position
It was evaluated with transesophageal echocardiography
• the first hour of returning to the supine position
It was evaluated with transesophageal echocardiography

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi Konuk Research Hospital	Istanbul	Bakirköy

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Beyls C, Daumin C, Hermida A, Booz T, Ghesquieres T, Crombet M, Martin N, Huette P, Jounieaux V, Dupont H, Abou-Arab O, Mahjoub Y. Association between the Right Ventricular Longitudinal Shortening Fraction and Mortality in Acute Respiratory Distress Syndr — View Citation

Evrard B, Goudelin M, Fedou AL, Vignon P. Hemodynamic response to prone ventilation in COVID-19 patients assessed with 3D transesophageal echocardiography. Intensive Care Med. 2020 Nov;46(11):2099-2101. doi: 10.1007/s00134-020-06217-w. Epub 2020 Aug 26. N — View Citation

Fossali T, Pavlovsky B, Ottolina D, Colombo R, Basile MC, Castelli A, Rech R, Borghi B, Ianniello A, Flor N, Spinelli E, Catena E, Mauri T. Effects of Prone Position on Lung Recruitment and Ventilation-Perfusion Matching in Patients With COVID-19 Acute Respiratory Distress Syndrome: A Combined CT Scan/Electrical Impedance Tomography Study. Crit Care Med. 2022 May 1;50(5):723-732. doi: 10.1097/CCM.0000000000005450. Epub 2022 Apr 11. — View Citation

Temperikidis P, Koroneos A, Xourgia E, Kotanidou A, Siempos II. Abnormal Right Ventricular Free Wall Strain Prior to Prone Ventilation May Be Associated With Worse Outcome of Patients With COVID-19-Associated Acute Respiratory Distress Syndrome. Crit Care — View Citation

Tonetti T, Grasselli G, Rucci P, Alessandri F, Dell'Olio A, Boscolo A, Pasin L, Sella N, Mega C, Melotti RM, Girardis M, Busani S, Bellani G, Foti G, Grieco DL, Scaravilli V, Protti A, Langer T, Mascia L, Pugliese F, Cecconi M, Fumagalli R, Nava S, Antone — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) change during prone position.	It was preferred right ventricular recovery evaluation.	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
Secondary	Static compliance (C-stat) change with prone position	It was examined in the evaluation of the pulmonary effect of prone position as secondary outcome.	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