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External Dead Space in Ventilated COVID-19 Patients

Primary Purpose

Coronavirus, ARDS, Human

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Removal of dead space filter
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronavirus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

-

Exclusion Criteria:

  • Exclusion criteria is ongoing ECMO treatment

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

dead space removal

Arm Description

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

Outcomes

Primary Outcome Measures

change in carbon dioxide elimination (VCO2) i.e. ml CO2 eliminated/minute
VCO2 is expected to increase after removal of the external dead space

Secondary Outcome Measures

Changes in alveolar dead space (a Vcap derived parameter)
Removing the external dead space is expected to decrease alveolar dead space (ml)
Changes in arterial carbon dioxide tension (PaCO2).
Removal of external dead space is expected to decrease PaCO2 (kPa).

Full Information

First Posted
June 7, 2020
Last Updated
May 27, 2021
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT04424082
Brief Title
External Dead Space in Ventilated COVID-19 Patients
Official Title
Influence of External Dead Space on Volumetric Capnography Derived Parameters in Mechanically Ventilated COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
May 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Covid-19 patients under mechanical ventilation are currently managed with a lung protective strategy derived from ARDSnet recommendations. In order to minimize the risk of spread of coronavirus, filters and associated respiratory tubing are incorporated to the breathing circuit, thus increasing apparatus dead space with subsequent increase in dead space ventilation. Considering the already often compromised ability for these patients to adequately clear carbon dioxide (VCO2), adding an external dead space can potentially have a substantial impact on CO2 homeostasis. The study will use volumetric capnography (Vcap) to investigate the influence of external dead space on VCO2 and calculated alveolar dead space. Objective: 1) To investigate the efficacy of Vcap to detect changes in dead space, VCO2 and shape factor parameters before and after disconnection of external dead space. 2) To register the external dead space impact on arterial carbon dioxide tension (PaCO2). 3) To calculate the alveolar dead space based on Vcap data and arterial blood gas analysis results. Design and setting: Prospective observational study in an intensive care center for Covid-19 patients in a university hospital. Patients: Covid-19 positive patients of all age groups under mechanical ventilation. Exclusion criteria is ongoing ECMO treatment Measurements and results: Vcap and Tcap parameters will be registered during mechanical ventilation and correlated to an arterial blood gas sample. Part of the apparatus dead space will then be reduced via removal of the heat and moister exchange filter (HME) with added tubing resulting in a reduction in volume of approximately 80 ml (i.e. the known volume of the HME filter and associated tubing). After the apparatus dead space is removed, the Vcap will be recorded for approximately 15 minutes and an arterial blood gas will be drawn at the end of the period. The HME and associated tubing will then be reattached to the breathing circuit and Vcap and Tcap parameters will be recorded for approximately 30 minutes and an arterial blood gas will be drawn. Vcap data will be analyzed for dead space, slope of phase III, VCO2 and associated shape factor parameters and compared with Tcap parameters. Changes in Vcap parameters will be tested for statistical significance using one and two-way ANOVA for repeated measures and Bland-Altman analysis will be used for comparison.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, ARDS, Human

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dead space removal
Arm Type
Other
Arm Description
external dead space will be removed and Vcap parameters (VCO2, PaCO2 and alveolar dead space) recorded before and after.
Intervention Type
Other
Intervention Name(s)
Removal of dead space filter
Intervention Description
Dead space filters will be removed and Vcap parameters (VCO2 ml/min, PaCO2 kPa, alveolar dead space in ml) recorded before and after removal
Primary Outcome Measure Information:
Title
change in carbon dioxide elimination (VCO2) i.e. ml CO2 eliminated/minute
Description
VCO2 is expected to increase after removal of the external dead space
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Changes in alveolar dead space (a Vcap derived parameter)
Description
Removing the external dead space is expected to decrease alveolar dead space (ml)
Time Frame
60 minutes
Title
Changes in arterial carbon dioxide tension (PaCO2).
Description
Removal of external dead space is expected to decrease PaCO2 (kPa).
Time Frame
60 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Covid-19 positive patients of all age groups under mechanical ventilation - Exclusion Criteria: Exclusion criteria is ongoing ECMO treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Persson, MD PhD
Organizational Affiliation
Karolinska University
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

External Dead Space in Ventilated COVID-19 Patients

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