NCT06947486

Brief Summary

This study aims to evaluate two different methods for calculating physiological dead space in adult patients undergoing invasive mechanical ventilation in the intensive care unit (ICU). Physiological dead space refers to the portion of air that is ventilated but does not participate in gas exchange due to impaired perfusion or ventilation-perfusion mismatch. Traditionally, dead space is calculated using the end-tidal carbon dioxide (EtCO₂) method, which estimates the difference between arterial and exhaled CO₂ values. However, this method may be influenced by circulatory failure or abnormal CO₂ distribution. An alternative method using the alveolar-arterial oxygen gradient \[P(A-a)O₂\] has been proposed, as it may provide a more stable measurement under critical conditions by relying on oxygenation efficiency rather than CO₂ elimination. In this prospective observational study, patients receiving mechanical ventilation in a tertiary ICU will be monitored. Physiological dead space will be calculated using both the EtCO₂-based method and the P(A-a)O₂-based method. Various respiratory and clinical parameters, including arterial blood gases, ventilator settings, and severity scores, will be recorded. The correlation between the two methods will be assessed, and their relationship with ICU mortality will be analyzed. The results of this study may help determine whether the P(A-a)O₂ method can be used as a reliable alternative for estimating dead space in ICU patients and whether it has prognostic value in predicting patient outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

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

January 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 20, 2025

Last Update Submit

April 20, 2025

Conditions

Keywords

Physiological Dead SpaceEtCO₂P(A-a)O₂ GradientMechanical VentilationVolumetric CapnographyVentilation-Perfusion MismatchEnghoff ModificationKuwabara EquationIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Correlation between EtCO₂- and P(A-a)O₂-based dead space calculations

    Description: Pearson or Spearman correlation coefficient calculated between dead space values obtained from EtCO₂ (Enghoff modification) and P(A-a)O₂-based gradient methods in mechanically ventilated ICU patients.

    Within the first 72 hours of ICU admission

Secondary Outcomes (3)

  • Association of each dead space method with ICU mortality

    From ICU admission until ICU discharge or death

  • Agreement between EtCO₂- and P(A-a)O₂-based dead space estimates

    Within first 3 days of ICU stay

  • Relationship between dead space values and gas exchange/ perfusion variables

    Daily for up to 72 hours

Study Arms (1)

Mechanically Ventilated ICU Patients

Adult patients (≥18 years old) admitted to a tertiary ICU and receiving invasive mechanical ventilation for at least 24 hours. Participants are prospectively monitored with capnographic and arterial blood gas measurements, and physiological dead space is calculated using both EtCO₂- and P(A-a)O₂-based methods. Patients are followed until ICU discharge or death.

Eligibility Criteria

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

The study population includes adult patients (aged 18 years and older) who are admitted to a tertiary academic intensive care unit and require invasive mechanical ventilation for respiratory failure. Eligible patients must be expected to remain intubated for at least 24 hours and undergo both volumetric capnography and arterial blood gas monitoring. Participants are enrolled prospectively and consecutively based on predefined inclusion and exclusion criteria. Patients with circulatory shock, severe metabolic or respiratory derangements, or technical limitations interfering with capnographic measurement are excluded. The study represents a critically ill cohort commonly encountered in ICU practice.

You may qualify if:

  • Age ≥ 18 years
  • Admission to the intensive care unit (ICU)
  • Receiving invasive mechanical ventilation
  • Expected ICU stay ≥ 24 hours
  • Availability of both arterial blood gas and volumetric capnography measurements
  • Central venous cathater for central venous blood analyses
  • Informed consent obtained from legal representative

You may not qualify if:

  • Refusal of participation by the patient or legal surrogate
  • Hemoglobin \< 7 g/dL
  • PaCO₂ \> 70 mmHg
  • Lactate \> 4 mmol/L
  • Capillary refill time \> 3 seconds
  • Mean arterial pressure (MAP) \< 65 mmHg
  • Mottling score ≥ 2
  • PaCO₂ - PcCO₂ gradient \> 8 mmHg
  • pH \< 7.20
  • Body temperature \> 38°C
  • BMI \> 40 kg/m²
  • VCO₂ \> 4 mL/kg/min
  • Technical limitations preventing accurate capnographic monitoring
  • Patients who are extubated, transferred, or deceased within the first 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University Faculty of Medicine, Department of Chest Diseases, Intensive Care Unit

Trabzon, 61080, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assist Prof.

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 27, 2025

Study Start

January 5, 2025

Primary Completion

April 10, 2025

Study Completion

April 18, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical and confidentiality considerations, and because no public data-sharing plan has been established for this study.

Locations