Work of Breathing Assessment During Weaning From Mechanical Ventilation

Mechanical Ventilation Clinical Trial

— WOAW  

Official title:

Work of Breathing Assessment During Weaning From Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762292
• Other study ID #: CHUSJ 2017-1259
• Status: Completed
• Phase: N/A
• Start date: June 7, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2018
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation
• Respiratory Aspiration

Intervention

Device:
• Measurement of work of breathing using indirect calorimeter
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.

Locations

Country	Name	City	State
Canada	St. Justine's Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oxygen Consumption, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.		Up to 2 hours from the beginning of the study
Primary	Change in Energy Expenditure, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.		Up to 2 hours from the beginning of the study
Secondary	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;	Up to 2 hours from the beginning of the study
Secondary	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;	Up to 2 hours from the beginning of the study
Secondary	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;	Up to 2 hours from the beginning of the study
Secondary	Change in Respiratory Rate	Respiratory Rate, monitored during the SBT;	Up to 2 hours from the beginning of the study
Secondary	Change in Cardiac Rate	Cardiac Rate, monitored during the SBT;	Up to 2 hours from the beginning of the study
Secondary	Duration of mechanical ventilation		Up to 3 months
Secondary	Spontaneous Breathing test success or failure	extubation success or failure (as defined by the need to re-intubate in the 24 hours following extubation).	Up to 28 hours