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

22. august 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 måned til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patienter
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Esophageal pressure
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 3 months
Up to 3 months
Spontaneous Breathing test success or failure
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

St. Justine's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juni 2016

Primær færdiggørelse (Faktiske)

30. juni 2017

Studieafslutning (Faktiske)

30. juni 2017

Datoer for studieregistrering

Først indsendt

28. april 2016

Først indsendt, der opfyldte QC-kriterier

2. maj 2016

Først opslået (Skøn)

4. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUSJ 2017-1259

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