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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05387356
Other study ID # Prone Position
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2022
Est. completion date June 10, 2022

Study information

Verified date May 2022
Source Kecioren Education and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thirty -one confirmed Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 ) infected patients with Acute Respiratory Distress Syndrome (ARDS) and placed in prone position(PP) for 3 times (PP1, PP2, PP3)consecutively will be included. Arterial blood gases (ABG), partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FiO2 ) ratios, partial pressure of carbondioxide (PaCO2), positive end expiratory pressure (PEEP), and fraction of inspired oxygen (FiO2) values will be recorded before (bPP), during (dPP)and after (aPP) every prone positioning. Eye, skin, nerve and tube complications related to prone positions wll be recorded


Recruitment information / eligibility

Status Recruiting
Enrollment 31
Est. completion date June 10, 2022
Est. primary completion date June 10, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. - Exclusion Criteria: negative test result for SARS-CoV-2 RNA -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
prone position
thirty-one patients who had a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. Medical datas of the patients will be obtained from patients' files which are strictly filled during pandemic. Prone position indication of intensive care unit (ICU) is in case of severe ARDS with PaO2/FiO2 <150 despite a PEEP >10 cmH2O.

Locations

Country Name City State
Turkey Health Sciences University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary effects of prone position The investigators will evaluate the arterial blood gase results and ventilator settings before after and during prone position 15 days
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