Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill Children (APPLE)

Background During ventilatory assistance, optimization of settings is critical to allow a personalized support and avoid over- or under-assistance. But little data are available in clinical practice to guide the adjustment of the support. In adults, esophageal pressure (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical studies suggest that PES may be useful to guide the management of mechanical ventilation. In children, the PES measurement could have similar potential benefits, but beforehand the reliability of PES to estimate PPL needs to be assessed.

Objective The primary objective of this study is to validate the reliability of PES directly monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate PPL, when compared to a gold standard, i.e the direct PPL measurement in situ.

Method This is a prospective single center study. Children <18 years old, hospitalized in the pediatric intensive care unit, requiring invasive ventilation and with at least one chest tube will be included.

Protocol A pressure transducer will be connected to the existing chest-tube and PES (measured by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be simultaneously recorded.

Expected results We expect that the PES-based methods will provide an accurate estimation of PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in children, and further interventional trials would be warranted to evaluate if its use could allow a reduction of the ventilation support duration.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Other: esophageal and pleural pressure measurement

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • St. Justine's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children <18 years old, hospitalized in the pediatric intensive care unit;
• Requiring invasive ventilation for more than 4 hours according to the prescription of the attending physician;
• With at least one chest tube.

Exclusion Criteria:

• Contraindications to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical or nasopharyngeal regions, severe coagulation disorder);
• Hemodynamic instability, as defined by the treating team, and the absence of recent (<4 hours) increase in the flow of dopamine, epinephrine, norepinephrine, or dobutamine;
• Respiratory instability defined as a severe respiratory failure requiring FiO2 > 60%, or PaCO2 > 80 mmHg on blood gas in the last hour;
• Persistent pleural effusion or pneumothorax despite the chest-tube;
• Bronchopleural fistula;
• Recent (<12 hours) thoracic hemorrhage;
• Delayed sternal closure at the time of study;
• Significant pericardial effusion;
• Absence of parental or tutor consent;
• Patient for whom a limitation of life support treatments is discussed or decided.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients; Patient baseline characteristics will be collected.; Specific nasogastric tube installation: a specific nasogastric tube equipped with pressure transducers (Gaeltec® probe) will be installed.; Connection of a pressure transducer to the existing chest-tube.; Simultaneous recordings of PES (Gaeltec®), PPL, PAW, respiratory volume and flow (5 minutes).; Removal of the Gaeltec® probe, and repositioning of the pre-existing nasogastric tube in the esophagus for PES measurement.; Simultaneous recordings of PES (feeding tube), PPL, PAW, respiratory volume and flow (5 minutes).; Repositioning of the nasogastric tube in the stomach, and disconnection of the different recording equipment.

Other: esophageal and pleural pressure measurement; Esophageal pressure will be monitored by a dedicated catheter and pleural pressure will be measured into the chest tube already in place

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-expiratory esophageal	End-expiratory PES and PL, calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts;	Up to 2 hours from the beginning of the study
Pleural pressure	PPL, directly measured in the existing chest tubes, and calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts.	Up to 2 hours from the beginning of the study
transpulmonary pressures		Up to 2 hours from the beginning of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Elastance-derived end-inspiratory transpulmonary pressure	The Elastance-derived end-inspiratory transpulmonary pressure, calculated as: PAW at end-inspiration x EL/ERS (EI and ERS being the respective elastances of the lung and the respiratory system, estimated on the esophageal and airway Pressure-Volume curves);	Up to 2 hours from the beginning of the study

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Children; Mechanical ventilation; Esophageal Pressure; Pleural Pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CHUSJ 2016-1238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No