NCT05474300

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

July 25, 2022

Last Update Submit

August 1, 2022

Conditions

Keywords

TslopePressure controlled ventilationmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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).

    100 minutes

Study Arms (1)

Covid-19 ARDS patients on PCV mode

No Intervention

Other: mechanical ventilation

Interventions

Pressure controlled ventilation mode on mechanical ventilation

Covid-19 ARDS patients on PCV mode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • adult patients with Covid-19 Acute Respiratory Distress Syndrome (ARDS) diagnosis
  • intubated Covid-19 ARDS patients
  • Covid-19 ARDS patients on mechanical ventilator support

You may not qualify if:

  • heart failure disease
  • Chronic Obstructive Pulmonary Disease (COPD)
  • hemodynamically unstable patients
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Dr sadi konuk Education hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31432217BACKGROUND
  • 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.

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • sinan asar, M.D

    intensive care supspecialist

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 26, 2022

Study Start

June 6, 2022

Primary Completion

August 6, 2022

Study Completion

August 30, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations