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Work of Breathing Assessment During Weaning From Mechanical Ventilation (WOAW)

22 augustus 2018 bijgewerkt door: Dr Guillaume Emeriaud, St. Justine's Hospital

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 maand tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Patiënten
Apparaat: Measurement of work of breathing using indirect calorimeter

  1. Preparation:

    1. Patient baseline characteristics will be collected.
    2. Connection of the Indirect Calorimeter to the respiratory circuit.
    3. 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.
  2. 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.
  3. End of the physiological recordings. Collection of Pediatric Intensive Care Unit (PICU) outcome of patients.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in Oxygen Consumption, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.
Tijdsspanne: Up to 2 hours from the beginning of the study
Up to 2 hours from the beginning of the study
Change in Energy Expenditure, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.
Tijdsspanne: Up to 2 hours from the beginning of the study
Up to 2 hours from the beginning of the study

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Esophageal pressure
Tijdsspanne: 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;
Up to 2 hours from the beginning of the study
Change in Esophageal pressure time product
Tijdsspanne: 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;
Up to 2 hours from the beginning of the study
Change in Electrical Activity of the diaphragm (EAdi)
Tijdsspanne: 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;
Up to 2 hours from the beginning of the study
Change in Respiratory Rate
Tijdsspanne: Up to 2 hours from the beginning of the study
Respiratory Rate, monitored during the SBT;
Up to 2 hours from the beginning of the study
Change in Cardiac Rate
Tijdsspanne: Up to 2 hours from the beginning of the study
Cardiac Rate, monitored during the SBT;
Up to 2 hours from the beginning of the study
Duration of mechanical ventilation
Tijdsspanne: Up to 3 months
Up to 3 months
Spontaneous Breathing test success or failure
Tijdsspanne: Up to 28 hours
extubation success or failure (as defined by the need to re-intubate in the 24 hours following extubation).
Up to 28 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

St. Justine's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 juni 2016

Primaire voltooiing (Werkelijk)

30 juni 2017

Studie voltooiing (Werkelijk)

30 juni 2017

Studieregistratiedata

Eerst ingediend

28 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

2 mei 2016

Eerst geplaatst (Schatting)

4 mei 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 augustus 2018

Laatste update ingediend die voldeed aan QC-criteria

22 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CHUSJ 2017-1259

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