External Dead Space in Ventilated COVID-19 Patients

Coronavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424082
• Other study ID #: Karolinska
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: May 27, 2021

Study information

• Verified date: May 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 27, 2021
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

-

Exclusion Criteria:

• Exclusion criteria is ongoing ECMO treatment

Related Conditions & MeSH terms

• ARDS, Human
• Coronavirus
• Respiratory Distress Syndrome, Adult

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in alveolar dead space (a Vcap derived parameter)	Removing the external dead space is expected to decrease alveolar dead space (ml)	60 minutes
Secondary	Changes in arterial carbon dioxide tension (PaCO2).	Removal of external dead space is expected to decrease PaCO2 (kPa).	60 minutes