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Completed

NCT Number: NCT04424082

External Dead Space in Ventilated COVID-19 Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 171 76, Sweden

About this study

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.

  • To register the external dead space impact on arterial carbon dioxide tension (PaCO2).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

-

Exclusion criteria

  • Exclusion criteria is ongoing ECMO treatment

Treatment and study plan

Removal of dead space filter

Other

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 outcomes

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

    Time frame: 60 minutes

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

Secondary outcomes

  1. Changes in alveolar dead space (a Vcap derived parameter)

    Time frame: 60 minutes

    Removing the external dead space is expected to decrease alveolar dead space (ml)

  2. Changes in arterial carbon dioxide tension (PaCO2).

    Time frame: 60 minutes

    Removal of external dead space is expected to decrease PaCO2 (kPa).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Influence of External Dead Space on Volumetric Capnography Derived Parameters in Mechanically Ventilated COVID-19 Patients

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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