Pediatric Acute Respiratory Distress Syndrome (PARDS)DECFVTTPMNCT06051292
Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement
A study testing Fast method and Conventional method in people with Pediatric Acute Respiratory Distress Syndrome (PARDS) and Acute Respiratory Failure, run by Dr. Behcet Uz Children's Hospital at 4 sites in Turkey (Türkiye).
Trial summary
Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- What is being tested?
- Fast method and Conventional method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 18 Sep 2023to 1 Oct 2026
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients between 1 months and 18 years
- Patients need mechanical ventilation support without modification of ventilation settings within the upcoming 2 hours
- Informed consent was signed by next of kin
- Requiring esophageal catheter application
Who cannot join
- Patients eligible for extubation or modification of ventilation settings within the upcoming 2 hours
- Patient included in another interventional study in the last 30 days
- Patients unable to undergo esophageal catheter insertion due to congenital or acquired pathologies
- Patient included in another interventional research study under consent
- Patient already enrolled in the present study in a previous episode of acute respiratory failure
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Aydin Obstetric and pediatrics Hospital
Aydin, 09020
Erzurum Regional Research and Training Hospital
Erzurum, 25180
Cam Sakura Research and Training Hospital
Istanbul, 34001
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Izmir, 35200
About this study
Official title: Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement
Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes).
However, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters.
To address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes
- Conditions
- Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- Being tested
- Fast method, Conventional method
- Keywords
- Acute respiratory failure (ARF), esophageal catheter, transpulmonary pressure
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast methodOther
Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements
Conventional methodOther
Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements
| Study group | Role | What they receive |
|---|---|---|
| Fast decremental | Experimental | fast decremental catheter volume titration will be applied Receives: Other: Fast method |
| Conventional | Active comparator | conventional catheter volume titration will be applied Receives: Other: Conventional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal catheter filling volume
The clinician will determine the optimal filling volume of the catheter using two distinct methods
Measured: up 1 hour after catheter placement
Secondary outcomes (2)
Transpulmonary driving pressure
The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter
Measured: up 1 hour after catheter placement
Time
The duration necessary to ascertain the optimal filling volume of the esophageal catheter
Measured: up 1 hour after catheter placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start18 Sep 2023
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Acute Respiratory Distress Syndrome (PARDS)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aydin Maternity and Child Health Hospital, Başakşehir Çam & Sakura City Hospital, Erzurum Regional Training & Research Hospital
- Responsible party
- Principal investigator, Hasan ağın, Dr. Behcet Uz Children's Hospital
- Investigators
- Hasan Agin, Professor, Study director, Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051292
- Sponsor's protocol ID
- 02020395
- Acronym
- DECFVTTPM
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mojoli F, Chiumello D, Pozzi M, Algieri I, Bianzina S, Luoni S, Volta CA, Braschi A, Brochard L. Esophageal pressure measurements under different conditions of intrathoracic pressure. An in vitro study of second generation balloon catheters. Minerva Anestesiol. 2015 Aug;81(8):855-64. Epub 2015 Jan 30.
PubMed 25634481Hotz JC, Sodetani CT, Van Steenbergen J, Khemani RG, Deakers TW, Newth CJ. Measurements Obtained From Esophageal Balloon Catheters Are Affected by the Esophageal Balloon Filling Volume in Children With ARDS. Respir Care. 2018 Feb;63(2):177-186. doi: 10.4187/respcare.05685. Epub 2017 Oct 31.
PubMed 29089460Mojoli F, Iotti GA, Torriglia F, Pozzi M, Volta CA, Bianzina S, Braschi A, Brochard L. In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable. Crit Care. 2016 Apr 11;20:98. doi: 10.1186/s13054-016-1278-5.
PubMed 27063290
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement
- ClinicalTrials.gov ID
- NCT06051292
- Acronym / sponsor ID
- DECFVTTPM / 02020395
- Conditions
- Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory failure (ARF), esophageal catheter, transpulmonary pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Collaborators
- Aydin Maternity and Child Health Hospital, Başakşehir Çam & Sakura City Hospital, Erzurum Regional Training & Research Hospital
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 22 Sep 2023 (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.
Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes).
However, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters.
To address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast decremental | Experimental | Other: Fast methodfast decremental catheter volume titration will be applied |
| Conventional | Active comparator | Other: Conventional methodconventional catheter volume titration will be applied |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients between 1 months and 18 years
- Patients need mechanical ventilation support without modification of ventilation settings within the upcoming 2 hours
- Informed consent was signed by next of kin
- Requiring esophageal catheter application
Key exclusion criteria (5 listed)
- Patients eligible for extubation or modification of ventilation settings within the upcoming 2 hours
- Patient included in another interventional study in the last 30 days
- Patients unable to undergo esophageal catheter insertion due to congenital or acquired pathologies
- Patient included in another interventional research study under consent
- Patient already enrolled in the present study in a previous episode of acute respiratory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast methodFast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements | Other | Fast decremental |
| Conventional methodConventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements | Other | Conventional |
Primary outcome
Optimal catheter filling volume
Time frame: up 1 hour after catheter placement
The clinician will determine the optimal filling volume of the catheter using two distinct methods
2 secondary outcomes
Transpulmonary driving pressure
Time frame: up 1 hour after catheter placement
Time
Time frame: up 1 hour after catheter placement
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 29 Oct 2026.
- Background: PubMed 25634481Mojoli F, Chiumello D, Pozzi M, Algieri I, Bianzina S, Luoni S, Volta CA, Braschi A, Brochard L. Esophageal pressure measurements under different conditions of intrathoracic pressure. An in vitro study of second generation balloon catheters. Minerva Anestesiol. 2015 Aug;81(8):855-64. Epub 2015 Jan 30.
- Background: PubMed 29089460Hotz JC, Sodetani CT, Van Steenbergen J, Khemani RG, Deakers TW, Newth CJ. Measurements Obtained From Esophageal Balloon Catheters Are Affected by the Esophageal Balloon Filling Volume in Children With ARDS. Respir Care. 2018 Feb;63(2):177-186. doi: 10.4187/respcare.05685. Epub 2017 Oct 31.
- Background: PubMed 27063290Mojoli F, Iotti GA, Torriglia F, Pozzi M, Volta CA, Bianzina S, Braschi A, Brochard L. In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable. Crit Care. 2016 Apr 11;20:98. doi: 10.1186/s13054-016-1278-5.
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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.
Hasan Agin, Professor study director
Behcet Uz Children's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast method and Conventional method in people with Pediatric Acute Respiratory Distress Syndrome (PARDS) and Acute Respiratory Failure, run by Dr. Behcet Uz Children's Hospital at 4 sites 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 5 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 29 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 4 sites 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?
Optimal catheter filling volume (time frame: up 1 hour after catheter placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051292, which also lists 3 linked publications.
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 29 Oct 2026.