NCT07654010

Brief Summary

End-tidal carbon dioxide (EtCO₂) refers to the level of carbon dioxide in the air exhaled during expiration and is measured using capnography. EtCO₂ is an important monitoring parameter in the management of critically ill patients on mechanical ventilation, providing indirect information about the patient's cardiac output, pulmonary perfusion-ventilation (V/Q) status, and metabolic activity. The Pa-EtCO₂ gradient, the difference between EtCO₂ and arterial CO₂ partial pressure (PaCO₂), changes significantly, especially in cases of hemodynamic deterioration, microcirculatory failure, and increased dead space. Therefore, the gradient is considered a potential indicator of perfusion in critically ill patients. In critically ill patients on mechanical ventilation, the usability of changes (courses) of the Pa-EtCO₂ gradient over time is being evaluated not only as an indicator of ventilation but also as a dynamic and indirect predictor of hemodynamic status and renal perfusion. Therefore, it should be investigated whether the Pa-EtCO2 gradient is a suitable parameter for early detection of AKI (acute kidney injury) development in patients with renal perfusion impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

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

March 15, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

April 9, 2026

Last Update Submit

June 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in PaCO₂-EtCO₂ Gradient at 6, 12, and 24 Hours After ICU Admission

    The PaCO₂-EtCO₂ gradient will be calculated as arterial carbon dioxide pressure minus end-tidal carbon dioxide pressure at baseline and at 6, 12, and 24 hours after ICU admission. Change from baseline will be reported for each follow-up time point in mmHg.

    Baseline, 6 hours, 12 hours, and 24 hours after ICU admission

Eligibility Criteria

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

patients being monitored with mechanical ventilators in intensive care

You may qualify if:

  • Patients over 18 years of age
  • patients under mechanical ventilation
  • initiation of EtCO₂ monitoring within the first hour of admission to the ICU
  • patients monitored in the ICU for at least 24 hours
  • having undergone arterial blood gas analysis (for PaCO₂ measurement) within the first 24 hours.

You may not qualify if:

  • Patients under 18 years of age
  • intensive care unit monitoring shorter than 24 hours
  • missing or inaccessible clinical data
  • chronic renal failure
  • acute renal failure present at admission to intensive care unit
  • advanced pulmonary diseases affecting EtCO₂ measurement (e.g., severe obstruction, giant bulla, advanced emphysema)
  • patients in whom PaCO₂ measurement cannot be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Training and Research Hospital

Malatya, Osmaniye, +90(505)620-3888, Turkey (Türkiye)

Location

Related Publications (3)

  • Defilippis V, D'Antini D, Cinnella G, Dambrosio M, Schiraldi F, Procacci V. End-tidal arterial CO2 partial pressure gradient in patients with severe hypercapnia undergoing noninvasive ventilation. Open Access Emerg Med. 2013 Jun 19;5:1-7. doi: 10.2147/OAEM.S43070. eCollection 2013.

  • Belenkiy SM, Berry JS, Batchinsky AI, Kendrick C, Necsoiu C, Jordan BS, Salinas J, Cancio LC. The noninvasive carbon dioxide gradient (NICO2G) during hemorrhagic shock. Shock. 2014 Jul;42(1):38-43. doi: 10.1097/SHK.0000000000000177.

  • Inan G, Kara Cetsmall i, Ukrainiannbsmall i, Ukrainianlek PH, Gonullu H. Comparison of End-Tidal Carbon Dioxide (ETCO2) Gradient and Vena Cava Collapsibility Index (VCCI) in Response to Intravenous Fluid Therapy in Patients with Moderate and Severe Dehydration and Acute Gastroenteritis. Prehosp Disaster Med. 2022 Aug;37(4):474-479. doi: 10.1017/S1049023X22000838. Epub 2022 May 25.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

June 17, 2026

Study Start

March 15, 2026

Primary Completion

May 15, 2026

Study Completion

June 5, 2026

Last Updated

June 17, 2026

Record last verified: 2026-01

Locations