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Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement (DECFVTTPM)

Primary Purpose

Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fast method
Conventional method
Sponsored by
Dr. Behcet Uz Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Acute Respiratory Distress Syndrome (PARDS) focused on measuring Acute respiratory failure (ARF), esophageal catheter, transpulmonary pressure

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Aydin Obstetric and pediatrics Hospital
  • Erzurum Regional Research and Training Hospital
  • Cam Sakura Research and Training Hospital
  • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fast decremental

Conventional

Arm Description

fast decremental catheter volume titration will be applied

conventional catheter volume titration will be applied

Outcomes

Primary Outcome Measures

Optimal catheter filling volume
The clinician will determine the optimal filling volume of the catheter using two distinct methods

Secondary Outcome Measures

Transpulmonary driving pressure
The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter
Time
The duration necessary to ascertain the optimal filling volume of the esophageal catheter

Full Information

First Posted
September 14, 2023
Last Updated
September 20, 2023
Sponsor
Dr. Behcet Uz Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06051292
Brief Title
Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement
Acronym
DECFVTTPM
Official Title
Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 18, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Behcet Uz Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Failure, Acute Respiratory Distress Syndrome
Keywords
Acute respiratory failure (ARF), esophageal catheter, transpulmonary pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fast decremental
Arm Type
Experimental
Arm Description
fast decremental catheter volume titration will be applied
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
conventional catheter volume titration will be applied
Intervention Type
Other
Intervention Name(s)
Fast method
Intervention Description
Fast decremental catheter volume titration will be applied and optimal filling volume will be determined according to the measurements
Intervention Type
Other
Intervention Name(s)
Conventional method
Intervention Description
Conventional catheter volume titration will be applied and optimal filling volume will be determined according to the measurements
Primary Outcome Measure Information:
Title
Optimal catheter filling volume
Description
The clinician will determine the optimal filling volume of the catheter using two distinct methods
Time Frame
up 1 hour after catheter placement
Secondary Outcome Measure Information:
Title
Transpulmonary driving pressure
Description
The measured transpulmonary driving pressure achieved using the optimal filling volume of the catheter
Time Frame
up 1 hour after catheter placement
Title
Time
Description
The duration necessary to ascertain the optimal filling volume of the esophageal catheter
Time Frame
up 1 hour after catheter placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan Agin, Professor
Phone
05362013162
Email
hasanagin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gokhan Ceylan, Associate Professor
Phone
0794542397
Email
drgokhanceylan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Agin, Professor
Organizational Affiliation
Behcet Uz Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aydin Obstetric and pediatrics Hospital
City
Aydın
ZIP/Postal Code
09020
Country
Turkey
Facility Name
Erzurum Regional Research and Training Hospital
City
Erzurum
ZIP/Postal Code
25180
Country
Turkey
Facility Name
Cam Sakura Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34001
Country
Turkey
Facility Name
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
City
Izmir
ZIP/Postal Code
35200
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25634481
Citation
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.
Results Reference
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PubMed Identifier
29089460
Citation
Hotz 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.
Results Reference
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PubMed Identifier
27063290
Citation
Mojoli 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.
Results Reference
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Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

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