Work of Breathing Assessment During Weaning From Mechanical Ventilation (WOAW)
Primary Purpose
Mechanical Ventilation
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Measurement of work of breathing using indirect calorimeter
Sponsored by
About this trial
This is an interventional other trial for Mechanical Ventilation focused on measuring Mechanical ventilation, Children, Work of breathing
Eligibility Criteria
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.
Sites / Locations
- St. Justine's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Outcomes
Primary Outcome Measures
Change in Oxygen Consumption, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.
Change in Energy Expenditure, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.
Secondary Outcome Measures
Change in Esophageal pressure
Esophageal, calculated as the mean value of 10 consecutive breaths, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
Change in Esophageal pressure time product
Pressure Time Product, calculated as the mean value of 10 consecutive breaths, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
Change in Electrical Activity of the diaphragm (EAdi)
EAdi, calculated as the mean inspiratory value during 1 minute, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
Change in Respiratory Rate
Respiratory Rate, monitored during the SBT;
Change in Cardiac Rate
Cardiac Rate, monitored during the SBT;
Duration of mechanical ventilation
Spontaneous Breathing test success or failure
extubation success or failure (as defined by the need to re-intubate in the 24 hours following extubation).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02762292
Brief Title
Work of Breathing Assessment During Weaning From Mechanical Ventilation
Acronym
WOAW
Official Title
Work of Breathing Assessment During Weaning From Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 7, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation
Keywords
Mechanical ventilation, Children, Work of breathing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Measurement of work of breathing using indirect calorimeter
Intervention Description
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 Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
Change in Esophageal pressure
Description
Esophageal, calculated as the mean value of 10 consecutive breaths, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
Time Frame
Up to 2 hours from the beginning of the study
Title
Change in Esophageal pressure time product
Description
Pressure Time Product, calculated as the mean value of 10 consecutive breaths, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
Time Frame
Up to 2 hours from the beginning of the study
Title
Change in Electrical Activity of the diaphragm (EAdi)
Description
EAdi, calculated as the mean inspiratory value during 1 minute, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
Time Frame
Up to 2 hours from the beginning of the study
Title
Change in Respiratory Rate
Description
Respiratory Rate, monitored during the SBT;
Time Frame
Up to 2 hours from the beginning of the study
Title
Change in Cardiac Rate
Description
Cardiac Rate, monitored during the SBT;
Time Frame
Up to 2 hours from the beginning of the study
Title
Duration of mechanical ventilation
Time Frame
Up to 3 months
Title
Spontaneous Breathing test success or failure
Description
extubation success or failure (as defined by the need to re-intubate in the 24 hours following extubation).
Time Frame
Up to 28 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
St. Justine's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
12. IPD Sharing Statement
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Work of Breathing Assessment During Weaning From Mechanical Ventilation
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