Cardiopulmonary Effects of Prone Position in CARDS

NCT06456606 | Completed DMC

• 1 other identifier: 2022/40
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS Due to Disease Caused by SARS Co-V-2; Right Ventricular Dysfunction

Keywords

transesophageal echocardiography; cards; heart lung interactions; prone position; right ventricle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

group a

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.

Procedure: before prone position; Procedure: the first hour of prone position; Procedure: the first hour of returning to the supine position

Interventions

before prone position PROCEDURE

It was evaluated with transesophageal echocardiography

Also known as: t0

group a

the first hour of prone position PROCEDURE

It was evaluated with transesophageal echocardiography

Also known as: t1

group a

the first hour of returning to the supine position PROCEDURE

It was evaluated with transesophageal echocardiography

Also known as: t2

group a

Eligibility Criteria

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

Study Population

moderate/severe C-ARDS patients admitted to the Bakırköy Dr Sadi Konuk Training and Research Hospital Anesthesiology and Reanimation Clinic Intensive Care Unit, who received invasive mechanical ventilation support and applied prone position in the first 48 h were included.

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research Hospital

Istanbul, Bakırköy, 34140, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 35200194 BACKGROUND

• 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. No abstract available.

  PMID: 32844261 RESULT

• 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 Syndrome Related to COVID-19 Infection: A Prospective Study. J Clin Med. 2022 May 6;11(9):2625. doi: 10.3390/jcm11092625.

  PMID: 35566751 RESULT

• 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 Explor. 2022 Jan 11;4(1):e0620. doi: 10.1097/CCE.0000000000000620. eCollection 2022 Jan.

  PMID: 35036925 RESULT

• 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, Antonelli M, Slutsky AS, Navalesi P, Pesenti A, Ranieri VM. Synergistic Effect of Static Compliance and D-dimers to Predict Outcome of Patients with COVID-19-ARDS: A Prospective Multicenter Study. Biomedicines. 2021 Sep 15;9(9):1228. doi: 10.3390/biomedicines9091228.

  PMID: 34572414 RESULT

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 13, 2024
• Study Start: February 1, 2022
• Primary Completion: April 10, 2022
• Study Completion: May 30, 2022
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)