- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474300
Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.
August 1, 2022 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Retrospective Evaluation of the Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.
The investigators are planning to investigate the effect of each 5% slope time change on mechanical power and SPO2 of the patients with Covid 19 ARDS diagnosis which are on mechanical ventilation PCV mode support.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
In this study, with inspiration/expiration 1:2 and 1:1 time ratios in pressure controlled ventilation mode with different slope times mechanical power will be calculated in covid ARDS patients.
In this way, the effect of every 5% slope time change in PCV on mechanical power and SPO2 will be investigated.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: sinan asar, M.D
- Phone Number: +905442659844
- Email: sinanasaras@gmail.com
Study Locations
-
-
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Istanbul, Turkey
- Recruiting
- Bakırköy Dr sadi konuk Education hospital
-
Contact:
- güneş özlem yildiz
- Phone Number: 905303603749
- Email: drgunesim@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients with Covid-19 ARDS diagnosis which has been admitted to intensive care unit, intubated and are on PCV mode on mechanical ventilation support will be included in the study.
Description
Inclusion Criteria:
- adult patients with Covid-19 Acute Respiratory Distress Syndrome (ARDS) diagnosis
- intubated Covid-19 ARDS patients
- Covid-19 ARDS patients on mechanical ventilator support
Exclusion Criteria:
- heart failure disease
- Chronic Obstructive Pulmonary Disease (COPD)
- hemodynamically unstable patients
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Covid-19 ARDS patients on PCV mode
No Intervention
|
Pressure controlled ventilation mode on mechanical ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mechanical power
Time Frame: 100 minutes
|
Mechanical power calculated by Becher et al. comprehensive formula (MPpcv(slope)) and Trinkle, Christine A et al lineer model mechanical power formula (MPLM).
|
100 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: sinan asar, M.D, intensive care supspecialist
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Becher T, van der Staay M. Calculation of mechanical power for pressure-controlled ventilation: author's reply. Intensive Care Med. 2019 Oct;45(10):1498-1499. doi: 10.1007/s00134-019-05742-7. Epub 2019 Aug 20. No abstract available.
- Trinkle CA, Broaddus RN, Sturgill JL, Waters CM, Morris PE. Simple, accurate calculation of mechanical power in pressure controlled ventilation (PCV). Intensive Care Med Exp. 2022 May 30;10(1):22. doi: 10.1186/s40635-022-00448-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2022
Primary Completion (Anticipated)
August 6, 2022
Study Completion (Anticipated)
August 30, 2022
Study Registration Dates
First Submitted
July 25, 2022
First Submitted That Met QC Criteria
July 25, 2022
First Posted (Actual)
July 26, 2022
Study Record Updates
Last Update Posted (Actual)
August 3, 2022
Last Update Submitted That Met QC Criteria
August 1, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID Numbers
- 2022/209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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