Cardiopulmonary Effects of Prone Position in CARDS

NCT ID: NCT06456606

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-05-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

before prone position

Intervention Type PROCEDURE

It was evaluated with transesophageal echocardiography

the first hour of prone position

Intervention Type PROCEDURE

It was evaluated with transesophageal echocardiography

the first hour of returning to the supine position

Intervention Type PROCEDURE

It was evaluated with transesophageal echocardiography

Interventions

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before prone position

It was evaluated with transesophageal echocardiography

Intervention Type PROCEDURE

the first hour of prone position

It was evaluated with transesophageal echocardiography

Intervention Type PROCEDURE

the first hour of returning to the supine position

It was evaluated with transesophageal echocardiography

Intervention Type PROCEDURE

Other Intervention Names

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t0 t1 t2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dicle Birtane

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bakirkoy Dr. Sadi Konuk Research Hospital

Istanbul, Bakırköy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35200194 (View on PubMed)

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.

Reference Type RESULT
PMID: 32844261 (View on PubMed)

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.

Reference Type RESULT
PMID: 35566751 (View on PubMed)

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.

Reference Type RESULT
PMID: 35036925 (View on PubMed)

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.

Reference Type RESULT
PMID: 34572414 (View on PubMed)

Other Identifiers

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2022/40

Identifier Type: -

Identifier Source: org_study_id

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