NCT04424082

Brief Summary

The objective is to investigate the efficacy of volumetric capnography to detect changes in dead space, CO2 elimination and shape factor parameters before and after disconnection of external dead space in ventilated COVID-19 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 9, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

16 days

First QC Date

June 7, 2020

Last Update Submit

May 27, 2021

Conditions

CoronavirusARDS, Human

Outcome Measures

Primary Outcomes (1)

  • change in carbon dioxide elimination (VCO2) i.e. ml CO2 eliminated/minute

    VCO2 is expected to increase after removal of the external dead space

    60 minutes

Secondary Outcomes (2)

  • Changes in alveolar dead space (a Vcap derived parameter)

    60 minutes

  • Changes in arterial carbon dioxide tension (PaCO2).

    60 minutes

Study Arms (1)

dead space removal

OTHER

external dead space will be removed and Vcap parameters (VCO2, PaCO2 and alveolar dead space) recorded before and after.

Other: Removal of dead space filter

Interventions

Removal of dead space filterOTHER

Dead space filters will be removed and Vcap parameters (VCO2 ml/min, PaCO2 kPa, alveolar dead space in ml) recorded before and after removal

dead space removal

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Covid-19 positive patients of all age groups under mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Coronavirus InfectionsRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Björn Persson, MD PhD

    Karolinska University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 9, 2020

Study Start

June 9, 2020

Primary Completion

June 25, 2020

Study Completion

May 27, 2021

Last Updated

May 28, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)