Invasive Mechanical VentilationIRIS-MAPNCT06963944
Physiological Dead Space and Intensive Care Mortality in Mechanically Ventilated Patients
An observational study of Invasive Mechanical Ventilation and Ventilation-Perfusion Mismatch, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Mechanical Ventilation, Ventilation-Perfusion Mismatch, ICU Mortality
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 19 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Physiological Dead Space and Intensive Care Unit Mortality in Mechanically Ventilated Adult Patients: A Prospective Observational Study
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.
Read the detailed description
Physiological dead space is defined as the portion of tidal volume that does not participate in effective gas exchange. It includes both anatomical and alveolar components and is a dynamic marker influenced by pulmonary perfusion, airway patency, ventilation settings, and lung pathology. In critically ill patients, particularly those receiving invasive mechanical ventilation, monitoring dead space may provide valuable insight into disease severity, ventilation-perfusion mismatch, and the adequacy of mechanical ventilation.
While capnography is routinely used in operating rooms and during anesthesia management, its role in intensive care units (ICUs) remains underutilized. Volumetric capnography offers a non-invasive, continuous method for assessing expired CO₂ and evaluating respiratory physiology in real time. Through the Enghoff-modified Bohr equation, physiological dead space can be calculated using the difference between arterial and end-tidal CO₂ (DS = (PaCO₂ - EtCO₂)/PaCO₂). This approach allows clinicians to quantify dead space without requiring invasive or complex instrumentation beyond standard ICU monitoring tools.
Previous research has identified an association between elevated dead space ventilation and increased mortality in conditions such as acute respiratory distress syndrome (ARDS), sepsis, and severe pneumonia. However, the utility of this parameter as a bedside prognostic tool in routine ICU practice remains limited by the lack of prospective validation and standardized monitoring protocols. Moreover, static measurements at a single time point may be insufficient to capture the clinical trajectory of critically ill patients, whereas trend analysis could provide more meaningful prognostic information.
This prospective observational study is designed to evaluate the relationship between physiological dead space and clinical outcomes, specifically ICU mortality and discharge disposition, in adult patients undergoing invasive mechanical ventilation. The study is conducted in a tertiary university hospital ICU and includes adult patients (≥18 years) who meet predefined inclusion criteria. Exclusion criteria are applied to eliminate potential confounders such as patients with noninvasive ventilation, pediatric cases, or those with significant technical limitations affecting capnographic measurements.
Data collection includes demographic characteristics, comorbidities, primary ICU admission diagnoses, ventilator parameters (tidal volume, PEEP, respiratory rate, minute ventilation, driving pressure), arterial blood gas values (PaO₂/FiO₂, PaCO₂), sedation level (RASS), vasoactive medication use, and daily volumetric capnography measurements (EtCO₂). Dead space values are recorded using standardized measurement windows, and time-series analysis is performed based on repeated observations during the ICU stay. The mode of discharge (survival, death, or transfer) is also documented.
The study aims to determine whether physiological dead space at ICU admission and its progression over time can serve as a reliable predictor of outcome. Additionally, it explores the feasibility of incorporating capnography-based dead space assessment into routine ICU monitoring as a noninvasive tool for early prognostication and ventilation optimization. Findings from this study may support broader use of volumetric capnography in intensive care medicine and contribute to individualized patient care strategies.
- Conditions
- Invasive Mechanical Ventilation, Ventilation-Perfusion Mismatch, ICU Mortality, Critical Illness, End Tidal CO2
- Keywords
- Physiological Dead Space, Volumetric Capnography, Enghoff Equation, Mechanical Ventilation, ICU, Critical Care, Ventilation-Perfusion Mismatch, PaCO₂, EtCO₂, ICU Mortality, Gas Exchange, Respiratory Monitoring
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
All-cause mortality during the intensive care unit (ICU) stay.
Measured: Up to ICU discharge day or 28 day
Secondary outcomes (4)
ICU Length of Stay
Number of days each patient spent in the ICU.
Measured: Through ICU stay, up to 28 days
Mechanical Ventilation Duration
Total number of days under invasive mechanical ventilation.
Measured: From initiation of invasive mechanical ventilation to extubation or death or, up to 28 days
Change in Physiological Dead Space Over Time
Temporal variation of physiological dead space calculated by Enghoff's modification of Bohr's equation (PaCO₂ - EtCO₂) / PaCO₂.
Measured: Daily measurements for up to 3 days in the ICU
Relationship Between Physiological Dead Space and Oxygenation
Correlation between dead space and oxygenation indices including PaO₂/FiO₂ ratio.
Measured: Daily during ICU stay (up to 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Nov 2024
- Primary completion19 Apr 2025
- Study completion19 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Oguzhan KUCUK, Karadeniz Technical University
- Investigators
- Mehtap Pehlivanlar Kucuk, MD, Assoc. Prof., Principal investigator, Karadeniz Technical University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963944
- Sponsor's protocol ID
- 2024/154
- Acronym
- IRIS-MAP
- Status last verified
- Oct 2026
- First submitted
- 20 Apr 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy considerations and the lack of a formal data-sharing infrastructure for this study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Physiological Dead Space and Intensive Care Unit Mortality in Mechanically Ventilated Adult Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06963944
- Acronym / sponsor ID
- IRIS-MAP / 2024/154
- Conditions
- Invasive Mechanical Ventilation, Ventilation-Perfusion Mismatch, ICU Mortality, Critical Illness, End Tidal CO2
- Keywords
- Physiological Dead Space, Volumetric Capnography, Enghoff Equation, Mechanical Ventilation, ICU, Critical Care, Ventilation-Perfusion Mismatch, PaCO₂
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 19 Apr 2025 (actual)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Physiological dead space is defined as the portion of tidal volume that does not participate in effective gas exchange. It includes both anatomical and alveolar components and is a dynamic marker influenced by pulmonary perfusion, airway patency, ventilation settings, and lung pathology. In critically ill patients, particularly those receiving invasive mechanical ventilation, monitoring dead space may provide valuable insight into disease severity, ventilation-perfusion mismatch, and the adequacy of mechanical ventilation.
While capnography is routinely used in operating rooms and during anesthesia management, its role in intensive care units (ICUs) remains underutilized. Volumetric capnography offers a non-invasive, continuous method for assessing expired CO₂ and evaluating respiratory physiology in real time. Through the Enghoff-modified Bohr equation, physiological dead space can be calculated using the difference between arterial and end-tidal CO₂ (DS = (PaCO₂ - EtCO₂)/PaCO₂). This approach allows clinicians to quantify dead space without requiring invasive or complex instrumentation beyond standard ICU monitoring tools.
Previous research has identified an association between elevated dead space ventilation and increased mortality in conditions such as acute respiratory distress syndrome (ARDS), sepsis, and severe pneumonia. However, the utility of this parameter as a bedside prognostic tool in routine ICU practice remains limited by the lack of prospective validation and standardized monitoring protocols. Moreover, static measurements at a single time point may be insufficient to capture the clinical trajectory of critically ill patients, whereas trend analysis could provide more meaningful prognostic information.
This prospective observational study is designed to evaluate the relationship between physiological dead space and clinical outcomes, specifically ICU mortality and discharge disposition, in adult patients undergoing invasive mechanical ventilation. The study is conducted in a tertiary university hospital ICU and includes adult patients (≥18 years) who meet predefined inclusion criteria. Exclusion criteria are applied to eliminate potential confounders such as patients with noninvasive ventilation, pediatric cases, or those with significant technical limitations affecting capnographic measurements.
Data collection includes demographic characteristics, comorbidities, primary ICU admission diagnoses, ventilator parameters (tidal volume, PEEP, respiratory rate, minute ventilation, driving pressure), arterial blood gas values (PaO₂/FiO₂, PaCO₂), sedation level (RASS), vasoactive medication use, and daily volumetric capnography measurements (EtCO₂). Dead space values are recorded using standardized measurement windows, and time-series analysis is performed based on repeated observations during the ICU stay. The mode of discharge (survival, death, or transfer) is also documented.
The study aims to determine whether physiological dead space at ICU admission and its progression over time can serve as a reliable predictor of outcome. Additionally, it explores the feasibility of incorporating capnography-based dead space assessment into routine ICU monitoring as a noninvasive tool for early prognostication and ventilation optimization. Findings from this study may support broader use of volumetric capnography in intensive care medicine and contribute to individualized patient care strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU Mortality
Time frame: Up to ICU discharge day or 28 day
All-cause mortality during the intensive care unit (ICU) stay.
4 secondary outcomes
ICU Length of Stay
Time frame: Through ICU stay, up to 28 days
Mechanical Ventilation Duration
Time frame: From initiation of invasive mechanical ventilation to extubation or death or, up to 28 days
Change in Physiological Dead Space Over Time
Time frame: Daily measurements for up to 3 days in the ICU
Relationship Between Physiological Dead Space and Oxygenation
Time frame: Daily during ICU stay (up to 3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy considerations and the lack of a formal data-sharing infrastructure for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehtap Pehlivanlar Kucuk, MD, Assoc. Prof. principal investigator
Karadeniz Technical University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Mechanical Ventilation and Ventilation-Perfusion Mismatch, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: Up to ICU discharge day or 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.