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

Mechanical Ventilation Clinical Trial

— APPLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762279
• Other study ID #: CHUSJ 2016-1238
• Status: Completed
• Phase: N/A
• Start date: June 28, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: August 2018
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
Canada	St. Justine's Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	transpulmonary pressures		Up to 2 hours from the beginning of the study
Secondary	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