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

22 augusti 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 månad till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Patienter
Enhet: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Esophageal pressure
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 3 months
Up to 3 months
Spontaneous Breathing test success or failure
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

St. Justine's Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 juni 2016

Primärt slutförande (Faktisk)

30 juni 2017

Avslutad studie (Faktisk)

30 juni 2017

Studieregistreringsdatum

Först inskickad

28 april 2016

Först inskickad som uppfyllde QC-kriterierna

2 maj 2016

Första postat (Uppskatta)

4 maj 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CHUSJ 2017-1259

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