Critical Care, Intensive CareNCT07383389
Validation of the Turkish RDOS Using End-Tidal Carbon Dioxide
An observational study of Critical Care, Intensive Care and Critical Illness, run by Istinye University.
Trial summary
Dyspnea is a complex and distressing symptom frequently observed in critically ill patients and is associated with increased morbidity, mortality, and prolonged intensive care unit (ICU) stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Intensive Care, Critical Illness
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 consists of adult patients aged 18 to 85 years who are hospitalized in the intensive care unit with clinically diagnosed dyspnea and underlying cardiopulmonary or systemic conditions. Eligible participants are patients who are unable to reliably self-report respiratory distress due to critical illness or impaired communication. Patients who are fully dependent on mechanical ventilation or have severe central nervous system disorders affecting respiratory control are excluded.
Who may be able to join
- Being 18 years of age or older,
- Having a diagnosis of lung or pleural cancer, chronic kidney failure, congestive heart failure, COPD, asthma, or pneumonia presenting with dyspnea,
- Being specifically referred for treatment of dyspnea,
- Having been in the intensive care unit for at least one day,
- Participation in the study must be consented to by the individual or a family member.
Who cannot join
- Being completely ventilator-dependent,
- Having a diagnosis of central nervous system disease (quadriplegia, bulbar ALS).
About this study
Official title: Validation of the Turkish Respiratory Distress Observation Scale Using End-Tidal Carbon Dioxide in Critical Care Patients
Dyspnea is a complex and distressing symptom frequently observed in critically ill patients and is associated with increased morbidity, mortality, and prolonged intensive care unit (ICU) stay. Although dyspnea is inherently subjective, accurate assessment of its presence and severity is essential for appropriate clinical decision-making and treatment planning. In routine clinical practice, dyspnea is commonly assessed using patient self-report scales; however, this approach is not feasible in patients who are unable to communicate due to impaired consciousness, cognitive dysfunction, mechanical ventilation, sedation, or severe illness. Consequently, there is a critical need for valid and reliable observational tools that allow healthcare professionals to assess respiratory distress in non-communicative patients.
The Respiratory Distress Observation Scale (RDOS) is an eight-item observational instrument originally developed to assess respiratory distress in patients who cannot self-report dyspnea. The scale evaluates observable physiological and behavioral indicators, including respiratory rate, heart rate, use of accessory muscles, paradoxical breathing, nasal flaring, grunting, restlessness, and facial expression. RDOS has demonstrated acceptable reliability and validity in various patient populations and has been translated into multiple languages. A Turkish version of the RDOS has recently undergone linguistic and cultural adaptation; however, its validity has not yet been examined using an objective physiological reference standard.
Read more
End-tidal carbon dioxide (ETCO₂), measured via capnography, provides a continuous, non-invasive indicator of ventilatory status and has been widely used in critically ill patients to monitor ventilation and respiratory adequacy. Alterations in ETCO₂ values may reflect changes in respiratory mechanics, ventilation-perfusion mismatch, and respiratory distress. Therefore, ETCO₂ represents a clinically relevant objective parameter for examining the concurrent validity of observational dyspnea assessment tools.
The primary objective of this study is to evaluate the validity of the Turkish version of the Respiratory Distress Observation Scale by examining its relationship with end-tidal carbon dioxide levels in critically ill adult patients hospitalized in the intensive care unit. This prospective observational study will be conducted over a six-month period in the ICU of a tertiary care hospital. A total of 64 adult patients aged 18 to 85 years who experience dyspnea and meet the inclusion criteria will be enrolled. Patients who are fully dependent on mechanical ventilation or have severe central nervous system disorders affecting respiratory control will be excluded.
Following ethical approval and informed consent obtained from patients' legal representatives, demographic and clinical data will be collected from medical records. Physiological parameters including oxygen saturation, respiratory rate, heart rate, blood pressure, body temperature, arterial blood gas values, and ETCO₂ will be recorded simultaneously. Disease severity will be assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The Turkish RDOS will be administered by a trained evaluator, and capnography measurements will be performed concurrently using appropriate mainstream or sidestream techniques depending on the patient's airway status.
Statistical analyses will include descriptive statistics and correlation analyses to examine the relationship between RDOS scores and ETCO₂ values. Concurrent and convergent validity will be evaluated using Pearson or Spearman correlation coefficients, depending on data distribution. It is hypothesized that higher RDOS scores, indicating more severe respiratory distress, will be associated with altered ETCO₂ levels, supporting the validity of the Turkish RDOS as an objective observational measure of dyspnea in critically ill patients.
The findings of this study are expected to provide important evidence supporting the clinical utility of the Turkish version of the Respiratory Distress Observation Scale for assessing respiratory distress in patients who are unable to self-report dyspnea. Establishing its validity against an objective physiological marker may facilitate more accurate monitoring of dyspnea, improve symptom management, and enhance the quality of care in intensive care settings.
- Conditions
- Critical Care, Intensive Care, Critical Illness
- 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 |
|---|---|---|
| Critical illness patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concurrent validity of the Turkish version of the Respiratory Distress Observation Scale (RDOS)
The concurrent validity of the Turkish version of the Respiratory Distress Observation Scale (RDOS), assessed by examining the relationship between RDOS total scores and end-tidal carbon dioxide (ETCO₂) levels in critically ill patients. The strength and direction of the association between RDOS scores and ETCO₂ values measured simultaneously via capnography will be analyzed to determine whether the RDOS reflects objective ventilatory status in patients unable to self-report dyspnea.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care, Intensive CareStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383389
- Sponsor's protocol ID
- 115
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Turkish Respiratory Distress Observation Scale Using End-Tidal Carbon Dioxide in Critical Care Patients
- ClinicalTrials.gov ID
- NCT07383389
- Acronym / sponsor ID
- 115
- Conditions
- Critical Care, Intensive Care, Critical Illness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 3 Feb 2026 (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.
Dyspnea is a complex and distressing symptom frequently observed in critically ill patients and is associated with increased morbidity, mortality, and prolonged intensive care unit (ICU) stay. Although dyspnea is inherently subjective, accurate assessment of its presence and severity is essential for appropriate clinical decision-making and treatment planning. In routine clinical practice, dyspnea is commonly assessed using patient self-report scales; however, this approach is not feasible in patients who are unable to communicate due to impaired consciousness, cognitive dysfunction, mechanical ventilation, sedation, or severe illness. Consequently, there is a critical need for valid and reliable observational tools that allow healthcare professionals to assess respiratory distress in non-communicative patients.
The Respiratory Distress Observation Scale (RDOS) is an eight-item observational instrument originally developed to assess respiratory distress in patients who cannot self-report dyspnea. The scale evaluates observable physiological and behavioral indicators, including respiratory rate, heart rate, use of accessory muscles, paradoxical breathing, nasal flaring, grunting, restlessness, and facial expression. RDOS has demonstrated acceptable reliability and validity in various patient populations and has been translated into multiple languages. A Turkish version of the RDOS has recently undergone linguistic and cultural adaptation; however, its validity has not yet been examined using an objective physiological reference standard.
End-tidal carbon dioxide (ETCO₂), measured via capnography, provides a continuous, non-invasive indicator of ventilatory status and has been widely used in critically ill patients to monitor ventilation and respiratory adequacy. Alterations in ETCO₂ values may reflect changes in respiratory mechanics, ventilation-perfusion mismatch, and respiratory distress. Therefore, ETCO₂ represents a clinically relevant objective parameter for examining the concurrent validity of observational dyspnea assessment tools.
The primary objective of this study is to evaluate the validity of the Turkish version of the Respiratory Distress Observation Scale by examining its relationship with end-tidal carbon dioxide levels in critically ill adult patients hospitalized in the intensive care unit. This prospective observational study will be conducted over a six-month period in the ICU of a tertiary care hospital. A total of 64 adult patients aged 18 to 85 years who experience dyspnea and meet the inclusion criteria will be enrolled. Patients who are fully dependent on mechanical ventilation or have severe central nervous system disorders affecting respiratory control will be excluded.
Following ethical approval and informed consent obtained from patients' legal representatives, demographic and clinical data will be collected from medical records. Physiological parameters including oxygen saturation, respiratory rate, heart rate, blood pressure, body temperature, arterial blood gas values, and ETCO₂ will be recorded simultaneously. Disease severity will be assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The Turkish RDOS will be administered by a trained evaluator, and capnography measurements will be performed concurrently using appropriate mainstream or sidestream techniques depending on the patient's airway status.
Statistical analyses will include descriptive statistics and correlation analyses to examine the relationship between RDOS scores and ETCO₂ values. Concurrent and convergent validity will be evaluated using Pearson or Spearman correlation coefficients, depending on data distribution. It is hypothesized that higher RDOS scores, indicating more severe respiratory distress, will be associated with altered ETCO₂ levels, supporting the validity of the Turkish RDOS as an objective observational measure of dyspnea in critically ill patients.
The findings of this study are expected to provide important evidence supporting the clinical utility of the Turkish version of the Respiratory Distress Observation Scale for assessing respiratory distress in patients who are unable to self-report dyspnea. Establishing its validity against an objective physiological marker may facilitate more accurate monitoring of dyspnea, improve symptom management, and enhance the quality of care in intensive care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical illness patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 85 years who are hospitalized in the intensive care unit with clinically diagnosed dyspnea and underlying cardiopulmonary or systemic conditions. Eligible participants are patients who are unable to reliably self-report respiratory distress due to critical illness or impaired communication. Patients who are fully dependent on mechanical ventilation or have severe central nervous system disorders affecting respiratory control are excluded.
Key inclusion criteria (5 listed)
- Being 18 years of age or older,
- Having a diagnosis of lung or pleural cancer, chronic kidney failure, congestive heart failure, COPD, asthma, or pneumonia presenting with dyspnea,
- Being specifically referred for treatment of dyspnea,
- Having been in the intensive care unit for at least one day,
- Participation in the study must be consented to by the individual or a family member.
Key exclusion criteria (2 listed)
- Being completely ventilator-dependent,
- Having a diagnosis of central nervous system disease (quadriplegia, bulbar ALS).
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
The concurrent validity of the Turkish version of the Respiratory Distress Observation Scale (RDOS)
Time frame: 4 Months
The concurrent validity of the Turkish version of the Respiratory Distress Observation Scale (RDOS), assessed by examining the relationship between RDOS total scores and end-tidal carbon dioxide (ETCO₂) levels in critically ill patients. The strength and direction of the association between RDOS scores and ETCO₂ values measured simultaneously via capnography will be analyzed to determine whether the RDOS reflects objective ventilatory status in patients unable to self-report dyspnea.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, Intensive Care and Critical Illness, run by Istinye University.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The concurrent validity of the Turkish version of the Respiratory Distress Observation Scale (RDOS) (time frame: 4 Months). 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 3 Feb 2026.