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Completed

NCT Number: NCT02762292

Work of Breathing Assessment During Weaning From Mechanical Ventilation

Introduction In patients assisted by mechanical ventilation, the Work Of Breathing (WOB) is shared between the patient and the ventilator. During weaning from mechanical ventilation, the WOB performed by the patient must be adequate and efficient to sustain spontaneous ventilation after extubation. The monitoring of WOB during weaning might allow a better management of the weaning process. Esophageal pressure (PES) is the reference technique to measure WOB but alternate tools have been proposed. The main hypothesis is that Indirect Calorimetry (IC) is valid to track the changes in energy expenditure due to the changes in WOB in mechanically ventilated children during weaning from mechanical ventilation. The primary objective of this study is to assess the validity of IC method for the WOB assessment when compared to PES measurement and Electrical Activity of the diaphragm (EAdi) during a spontaneous breathing trial (SBT) in continuous positive airway pressure, which is a routine extubation readiness test which generally induces an increase in WOB.

Methods This is a prospective single center study. All intubated and mechanically ventilated children >1 months and <18 years old, hospitalized in the pediatric intensive care unit will be eligible.

Simultaneous recordings of Energy Expenditure, PES and EAdi will be performed during 3 steps: before, during and after the SBT. Then outcome of patients will be collected.

The investigators plan to study a sample of 15 patients to be representative.

Relevance to the importance of child health in Canada The investigators expect that the IC-based less invasive method will provide an accurate estimation of WOB assessment. Once this tool is validated, the interest of IC to (i) early detect an increase in WOB during mechanical ventilation in children, (ii) to assess the ability to extubate them and (iii) to optimize nutritional support will be assessed in future studies.

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Key information

Age range

1 month–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

All intubated and mechanically ventilated children >1 months and <18 years old, hospitalized in the pediatric intensive care unit will be eligible.

The patient is deemed to be ready for an extubation readiness test as per the attending team. In particular, the following criteria should be met:

  • Improvement in the underlying condition that led to intubation;
  • Presence of spontaneous breathing, and adequate oxygenation:, FiO2 ≤ 0.6 (to obtain a SpO2 between 92 and 97%), with Positive End Expiratory Pressure < 8 cmH2O;
  • Adequate mental status: Arousal;
  • Effective cough;
  • No planned operative procedure requiring heavy sedation in the next 12 hours.

Exclusion criteria

  • Contraindications to the placement of a new nasogastric tube (e.g. trauma or recent surgery in cervical, esophageal, or nasopharyngeal regions, severe coagulation disorder);
  • Hemodynamic instability requiring milrinone ≥ 0.5µg/kg/min, dopamine ≥ 5µg/kg/min, epinephrine ≥ 0.03µg/kg/min, norepinephrine ≥ 0.03µg/kg/min, or dobutamine ≥ 5µg/kg/min;
  • Severe respiratory instability, and in particular PaCO2 > 80 mmHg on the last blood gas in the last 4 hours;
  • Axillary temperature >38°;
  • Cuff leaks >10%, calculated by the ventilator as mean inspired tidal volume minus mean expired tidal volume divided by inspired tidal volume;
  • Absence of parental or tutor consent;
  • Patient for whom a limitation of life support treatments is discussed or decided.

Treatment and study plan

Measurement of work of breathing using indirect calorimeter

Device
  • Preparation:
  • Patient baseline characteristics will be collected.
  • Connection of the Indirect Calorimeter to the respiratory circuit.
  • Nasogastric tube installation: a specific modified Neurally Adjusted Ventilatory Assist (NAVA) catheter equipped with both microelectrodes for Electrical Activity of the diaphragme (EAdi) monitoring and an esophageal balloon (for esophageal pressure (PES) monitoring) will be installed.
  • Simultaneous recordings of: Oxygen Consumption (VO2) and Energy Expenditure (EE); Esophageal Pressure (PES), Airway Pressure (PAW), respiratory volume and flow; EAdi during (i) Conventional mechanical ventilation (ii) Spontaneous Breathing Trial in Continuous Positive Airway Pressure and (iii) Second period of Conventional mechanical ventilation with the same ventilator parameters set in STEP 1.
  • End of the physiological recordings. Collection of Pediatric Intensive Care Unit (PICU) outcome of patients.

Primary outcomes

  1. Change in Oxygen Consumption, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.

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

  2. Change in Energy Expenditure, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.

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

Secondary outcomes

  1. Change in Esophageal pressure

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

    Esophageal, calculated as the mean value of 10 consecutive breaths, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;

  2. Change in Esophageal pressure time product

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

    Pressure Time Product, calculated as the mean value of 10 consecutive breaths, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;

  3. Change in Electrical Activity of the diaphragm (EAdi)

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

    EAdi, calculated as the mean inspiratory value during 1 minute, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;

  4. Change in Respiratory Rate

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

    Respiratory Rate, monitored during the SBT;

  5. Change in Cardiac Rate

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

    Cardiac Rate, monitored during the SBT;

  6. Duration of mechanical ventilation

    Time frame: Up to 3 months

  7. Spontaneous Breathing test success or failure

    Time frame: Up to 28 hours

    extubation success or failure (as defined by the need to re-intubate in the 24 hours following extubation).

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Acronym: WOAW

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.

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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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