COVID-19 PneumoniaNCT05474300
Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.
An observational study of COVID-19 Pneumonia and COVID-19 Acute Respiratory Distress Syndrome, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- mechanical ventilation
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 30 Aug 2022
- 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: 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.
Who may be able to join
- adult patients with Covid-19 Acute Respiratory Distress Syndrome (ARDS) diagnosis
- intubated Covid-19 ARDS patients
- Covid-19 ARDS patients on mechanical ventilator support
Who cannot join
- heart failure disease
- Chronic Obstructive Pulmonary Disease (COPD)
- hemodynamically unstable patients
- pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakırköy Dr sadi konuk Education hospital
Istanbul
güneş özlem yildiz, 905303603749, drgunesim@hotmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- mechanical ventilation
- Keywords
- Tslope, Pressure controlled ventilation, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationOther
Pressure controlled ventilation mode on mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 ARDS patients on PCV mode | No Intervention Receives: Other: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical power
Mechanical power calculated by Becher et al. comprehensive formula (MPpcv(slope)) and Trinkle, Christine A et al lineer model mechanical power formula (MPLM).
Measured: 100 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start6 Jun 2022
- Primary completion6 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- sinan asar, M.D, Study director, intensive care supspecialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474300
- Sponsor's protocol ID
- 2022/209
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31432217Trinkle 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.
PubMed 35644896
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.
- ClinicalTrials.gov ID
- NCT05474300
- Acronym / sponsor ID
- 2022/209
- Keywords
- Tslope, Pressure controlled ventilation, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 6 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 26 Jul 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 ARDS patients on PCV mode | – | Other: mechanical ventilationNo Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- adult patients with Covid-19 Acute Respiratory Distress Syndrome (ARDS) diagnosis
- intubated Covid-19 ARDS patients
- Covid-19 ARDS patients on mechanical ventilator support
Key exclusion criteria (4 listed)
- heart failure disease
- Chronic Obstructive Pulmonary Disease (COPD)
- hemodynamically unstable patients
- pregnancy
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 |
|---|---|---|
| mechanical ventilationPressure controlled ventilation mode on mechanical ventilation | Other | Covid-19 ARDS patients on PCV mode |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 31432217Becher 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.
- Results publication: PubMed 35644896Trinkle 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.
- Individual participant dataSharing planned: Undecided
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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.
sinan asar, M.D study director
intensive care supspecialist
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 COVID-19 Pneumonia and COVID-19 Acute Respiratory Distress Syndrome, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sinan asar, M.D (+905442659844, sinanasaras@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical power (time frame: 100 minutes). 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 NCT05474300, which also lists 2 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 3 Aug 2022.