NCT06963944

Brief Summary

This study investigates the relationship between physiological dead space and clinical outcomes, specifically mortality and discharge status, in adult patients receiving invasive mechanical ventilation in the intensive care unit (ICU). Physiological dead space refers to ventilated but non-perfused regions of the lungs and can be quantified using the Enghoff-modified Bohr equation based on capnographic and arterial CO₂ measurements. While volumetric capnography is a valuable tool in anesthesiology and perioperative care, its use in ICU settings remains limited. By continuously monitoring physiological dead space at the bedside, this study aims to provide real-time insight into ventilation-perfusion mismatch and assess its prognostic significance in critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

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

Study Start

First participant enrolled

January 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
Last Updated

May 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 20, 2025

Last Update Submit

April 30, 2025

Conditions

Keywords

Physiological Dead SpaceVolumetric CapnographyEnghoff EquationMechanical VentilationICUCritical CareVentilation-Perfusion MismatchPaCO₂EtCO₂ICU MortalityGas ExchangeRespiratory Monitoring

Outcome Measures

Primary Outcomes (1)

  • ICU Mortality

    All-cause mortality during the intensive care unit (ICU) stay.

    Up to ICU discharge day or 28 day

Secondary Outcomes (4)

  • ICU Length of Stay

    Through ICU stay, up to 28 days

  • Mechanical Ventilation Duration

    From initiation of invasive mechanical ventilation to extubation or death or, up to 28 days

  • Change in Physiological Dead Space Over Time

    Daily measurements for up to 3 days in the ICU

  • Relationship Between Physiological Dead Space and Oxygenation

    Daily during ICU stay (up to 3 days)

Study Arms (1)

Mechanically Ventilated Adult ICU Patients

Adult patients (aged ≥18 years) who received invasive mechanical ventilation in a tertiary intensive care unit. All participants were prospectively monitored with volumetric capnography and arterial blood gas analysis to evaluate physiological dead space. No interventions were applied as part of the study.

Eligibility Criteria

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

The study population consisted of adult patients (aged 18 years and older) who were admitted to a tertiary academic intensive care unit and required invasive mechanical ventilation for respiratory failure of various etiologies. All patients were managed in the ICU setting with advanced monitoring capabilities, including arterial blood gas analysis and volumetric capnography. Patients were enrolled consecutively during the study period based on predefined eligibility criteria. Individuals with hemodynamic instability, severe acidosis, or technical limitations preventing accurate dead space measurement were excluded. The study population reflects a critically ill cohort typically encountered in university hospital ICUs.

You may qualify if:

  • Admitted to the intensive care unit
  • Receiving invasive mechanical ventilation
  • Monitored with volumetric capnography and arterial blood gas analysis
  • Informed consent obtained from legal representatives

You may not qualify if:

  • Patients under 18 years of age
  • ICU length of stay less than 24 hours
  • Patient or legal representative refused participation
  • Hemoglobin level \< 7 g/dL
  • Arterial PaCO₂ \> 70 mmHg
  • Signs of circulatory failure
  • Lactate \> 4 mmol/L
  • Capillary refill time \> 3 seconds
  • PaCO₂ - Central venous CO₂ gradient \> 8 mmHg (if applicable)
  • Mean arterial pressure (MAP) \< 65 mmHg
  • Mottling score ≥ 2
  • Body temperature \> 38°C
  • Arterial pH \< 7.20
  • Body mass index (BMI) \> 40 kg/m²
  • Carbon dioxide production (VCO₂) \> 4 mL/kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mehtap Pehlivanlar Kucuk, MD, Assoc. Prof.

    Karadeniz Technical University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

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

May 9, 2025

Study Start

January 1, 2024

Primary Completion

April 19, 2025

Study Completion

April 19, 2025

Last Updated

May 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy considerations and the lack of a formal data-sharing infrastructure for this study.

Locations