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Completed

NCT Number: NCT02762279

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

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.

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Key information

Conditions

Mechanical Ventilation

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Justine's Hospital

Montreal, Quebec, H3T 1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

esophageal and pleural pressure measurement

Other

Esophageal pressure will be monitored by a dedicated catheter and pleural pressure will be measured into the chest tube already in place

Primary outcomes

  1. End-expiratory esophageal

    Time frame: Up to 2 hours from the beginning of the study

    End-expiratory PES and PL, calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts;

  2. Pleural pressure

    Time frame: Up to 2 hours from the beginning of the study

    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.

  3. transpulmonary pressures

    Time frame: Up to 2 hours from the beginning of the study

Secondary outcomes

  1. The Elastance-derived end-inspiratory transpulmonary pressure

    Time frame: Up to 2 hours from the beginning of the study

    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);

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Acronym: APPLE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 4, 2016
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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