NCT04873336

Brief Summary

Transpulmonary pressure may be higher in ARDS patients due to decreased respiratory system compliance. The hypothesis is that tidal volumes which are generated by Intellivent- Adaptive support ventilation (ASV) are safe range by transpulmonary pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

May 4, 2021

Last Update Submit

November 15, 2021

Conditions

Covid19ARDS

Keywords

Mechanical ventilationAdaptive support ventilationTranspulnonary pressureSafety

Outcome Measures

Primary Outcomes (1)

  • Inspiratory Transpulmonary Pressure (Ptpins)

    Ptpinsp will be measured with an inspiratory hold maneuver

    The first 24 hours of mechanical ventilation

Secondary Outcomes (1)

  • Expiratory Transpulmonary Pressure (Ptexp)

    The first 24 hours of mechanical ventilation

Interventions

Intellivent ASVDEVICE

A closed loop mechanical ventilation mode that adjusts oxygenization and ventilation automatically

Eligibility Criteria

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

Patient with COVID-19 who received invasive mechanical ventilation due to respiratory failure in intensive care unit

You may qualify if:

  • COVID-19 is confirmed with RT-PCR
  • \>18 years of age
  • Being intubated less than 24 hours
  • Not being planned to be extubated in 24 hours

You may not qualify if:

  • COVID-19 is not confirmed with RT-PCR
  • Having an impaired hemodynamic status
  • Esophageal pathologies
  • Bronchopleural fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit

Izmir, 35110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Suleyman Yildirim, M.D.

    University of Health Sciences, Dr. Suat Seren Chest Diseases and Surgery Training and Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor Cenk KIRAKLI

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 5, 2021

Study Start

April 1, 2021

Primary Completion

October 15, 2021

Study Completion

October 16, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)