ARDS Due to Disease Caused by SARS Co-V-2NCT06456606
Cardiopulmonary Effects of Prone Position in CARDS
An observational study of ARDS Due to Disease Caused by SARS Co-V-2 and Right Ventricular Dysfunction, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS Due to Disease Caused by SARS Co-V-2, Right Ventricular Dysfunction
- What is being tested?
- before prone position, the first hour of prone position and the first hour of returning to the supine position
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 May 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- >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
Who cannot join
- Pulmonary embolism
- Pneumothorax
- Heart valve disease
- Pregnancy
- Perforated esophageal varices
- Coagulopathy
Show all 14Show fewer
- Esophageal stricture
- Esophageal tumor
- Neck fracture
- Thrombocytopenia
- Gastrointestinal bleeding
- Previous stomach surgery
- Previous esophageal surgery
- Esophageal perforation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research Hospital
Istanbul, Bakırköy, 34140
About this study
Official title: The Effect of Prone Position on Right Ventricular Functions in CARDS: is Survival Predictable When Evaluated Through Transesophageal Echocardiography?
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.
Read the 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.
- Being tested
- before prone position, the first hour of prone position, the first hour of returning to the supine position
- Keywords
- transesophageal echocardiography, cards, heart lung interactions, prone position, right ventricle
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
before prone positionProcedure or surgery
Also called t0
It was evaluated with transesophageal echocardiography
the first hour of prone positionProcedure or surgery
Also called t1
It was evaluated with transesophageal echocardiography
the first hour of returning to the supine positionProcedure or surgery
Also called t2
It was evaluated with transesophageal echocardiography
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: before prone position; Procedure: the first hour of prone position; Procedure: the first hour of returning to the supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) change during prone position.
It was preferred right ventricular recovery evaluation.
Measured: 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 examined in the evaluation of the pulmonary effect of prone position as secondary outcome.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Feb 2022
- Primary completion10 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ARDS Due to Disease Caused by SARS Co-V-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dicle Birtane, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456606
- Sponsor's protocol ID
- 2022/40
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available from the publication date can start If requested, data will be shared with medical doctors dealing with
Publications
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.
PubMed 35200194Evrard 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.
PubMed 32844261Beyls 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.
PubMed 35566751Temperikidis 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.
PubMed 35036925Tonetti 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.
PubMed 34572414
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prone Position on Right Ventricular Functions in CARDS: is Survival Predictable When Evaluated Through Transesophageal Echocardiography?
- ClinicalTrials.gov ID
- NCT06456606
- Acronym / sponsor ID
- 2022/40
- Keywords
- transesophageal echocardiography, cards, heart lung interactions, prone position, right ventricle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group a | – | Procedure: before prone position, Procedure: the first hour of prone position, Procedure: the first hour of returning to the supine position30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (14 listed)
- Pulmonary embolism
- Pneumothorax
- Heart valve disease
- Pregnancy
- Perforated esophageal varices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| before prone positionAlso: t0It was evaluated with transesophageal echocardiography | Procedure or surgery | group a |
| the first hour of prone positionAlso: t1It was evaluated with transesophageal echocardiography | Procedure or surgery | group a |
| the first hour of returning to the supine positionAlso: t2It was evaluated with transesophageal echocardiography | Procedure or surgery | group a |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 35200194Fossali 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.
- Results publication: PubMed 32844261Evrard 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.
- Results publication: PubMed 35566751Beyls 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.
- Results publication: PubMed 35036925Temperikidis 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.
- Results publication: PubMed 34572414Tonetti 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.
- Individual participant dataSharing planned: Yes. Data available from the publication date can start If requested, data will be shared with medical doctors dealing with
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS Due to Disease Caused by SARS Co-V-2 and Right Ventricular Dysfunction, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456606, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.