WOB and Paediatric Mechanical Ventilation

NCT05254691 | Completed

• 1 other identifier: NL38361.042.11
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The most common approach to weaning infants and children is gradual reduction of ventilatory support ("traditional approach"). Alternatively, another approach to weaning is attempted with alternating periods of complete ventilatory support and graded spontaneous breathing with assistance ("sprinting approach"). Both approaches are used randomly in our unit: the decision to use which approach is dependent upon the preferences of the attending physician as described in many observational single center studies. To date, there is no data comparing the safety and efficacy of the "sprinting" approach with more traditional approaches of weaning in children. Hence, numerous issues remain unanswered, including the work-of-breathing during each approach. For this research proposal, we want to measure the work-of-breathing daily, using the traditional approach (the area under the oesophageal pressure - volume curve) and study its correlation with clinical parameters and EMG activity of the diaphragm and intercostal muscles from the moment that the patient is weaned off the ventilator. Objective: The primary objective for this study is to compare for each patient of the work-of-breathing during the "sprinting"approach and the "traditional approach.The secondary objectives for this study are to compare the oesophageal pressure rate and (PRP) and pressure time product (PTP), the PaO2/FiO2 ratio, global and regional distribution of tidal volume measured using electrical impedance tomography (EIT), phase distribution of the respiratory inductive plethysmography (RIP) signal and the EMG activity of the diaphragm and intercostal muscles between the "sprinting"and the "traditional" approach.. Study design: This is a prospective exploratory study with invasive measurements in a 20 bed tertiary paediatric intensive care facility at the Beatrix Children's Hospital/University Medical Centre Groningen. Study population: All mechanically ventilated children aged 0 to 5 years with or without lung pathology admitted to the paediatric intensive care unit are eligible for inclusion. Inclusion criteria include mechanical ventilation for at least 48 hours, weight ≥ 3 kg, sufficient respiratory drive present, deemed eligible for weaning by the attending physician, and stable haemodynamics (defined by the absence of need for increase in vaso-active drugs and/or fluid challenges at least 6 hours prior to enrolment). Exclusion criteria include mechanical ventilation less than 48 hours, not eligible for weaning (usually when there are unstable ventilator settings, defined by the need for increase of inspiratory pressures or positive end-expiratory pressure, and a FiO2 \> 0.6 within 6 hours prior to enrolment), unstable haemodynamics (defined by the need for increase in vaso-ative drugs and/or fluid challenges within 6 hours prior to enrolment), leakage around the endotracheal tube \> 5%, admitted to the neonatal intensive care unit, preterm birth with gestational age corrected for post-conceptional age less than 40 weeks, congenital or acquired neuromuscular disorders, congenital or acquired central nervous system disorders with depressed respiratory drive, congenital or acquired damage to the phrenic nerve, congenital or acquired paralysis of the diaphragm, use of neuromuscular blockade prior to enrolment, uncorrected congenital heart disorder, and chronic lung disease. Main study parameters/endpoints: The main study parameter is the level and time course of the patient's work-of-breathing mathematically calculated by the area under the pressure-volume curve Secondary study parameters include the level and time course of the PRP and PTP, level and time course of oxygenation (PaO2/FiO2 ratio), global and regional distribution of tidal volume, phase distribution, EMG activity of the diaphragm and intercostal muscles, heart rate, respiratory rate.. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are a priori no specific benefits for the patients who participate in the study.

Conditions

Pediatric Respiratory Diseases; Ventilator Weaning; Respiration, Artificial; Respiratory Failure; Pediatrics; Work of Breathing

Keywords

pediatrics; mechanical ventilation; work of breathing

Outcome Measures

Primary Outcomes (1)

• The work of breathing (Campbell Diagram)

  The level and time course of the patient work-of-breathing measured by the area under the pressure-volume curve during PS ventilation with the work-of-breathing during SIMV-PS ventilation with a lower rate of breaths per minute delivered by the ventilator.

  10 minutes

Secondary Outcomes (2)

• Pressure-time-product (PTP)

  10 minutes

• Pressure-rate-product (PRP)

  10 minutes

Study Arms (2)

Standard care

NO INTERVENTION

All children are put on a time-cycled, pressure limited ventilation mode (AVEA, CareFusion, Yorba Linda, CA, USA). Inspiratory pressures are set to deliver a expiratory tidal volume of 5-7 ml/kg ideal bodyweight. The frequency of the delivered machine-breaths is set in accordance with age and disease condition of the patient. Then the patient set rate of breaths per minute delivered by the ventilator is reduced with 25%, allowing for more spontaneous breaths.

Sprinting

EXPERIMENTAL

The ventilator mode is switched to PS ventilation. The level of PS is set to meet the level of PS set when the patient is ventilated in the SIMV-PS mode. The patient will be in the PS mode until he or she clinically shows increased work-of-breathing (tachypnoea and the presence of nasal flaring and intercostal and/or interjugular retractions indicate increased work of breathing).

Procedure: Sprinting

Interventions

Sprinting PROCEDURE

The ventilator mode is switched to PS ventilation. The level of PS is set to meet the level of PS set when the patient is ventilated in the SIMV-PS mode. The patient will be in the PS mode until he or she clinically shows increased work-of-breathing (tachypnoea and the presence of nasal flaring and intercostal and/or interjugular retractions indicate increased work of breathing). This "sprinting" is performed on the theory that the respiratory muscles can be slowly trained to sustain complete spontaneous breathing. Also, theoretically this "sprinting" allows a better global and regional distribution of the tidal volume in the lung.

Sprinting

Eligibility Criteria

• Age: 0 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• mechanical ventilation for at least 48 hours before the start of weaning
• weight ≥ 3 kg
• deemed eligible for weaning by the attending physician, i.e. able to initiate and maintain spontaneous breathing.
• stable haemodynamics, defined by the absence of need for increase in vaso-active drugs and/or fluid challenges at least 6 hours prior to enrolment

You may not qualify if:

• mechanical ventilation less than 48 hours for unplanned admissions before the start of weaning
• post-operative admission with expected duration of mechanical ventilaton less than 48 hours
• not eligible for weaning as assessed by the attending physician (usually when there are unstable ventilator settings, defined by the need for increase of inspiratory pressures or positive end-expiratory pressure, and a FiO2 \> 0.6 within 6 hours prior to enrolment)
• unstable haemodynamics, defined by the need for increase in vaso-active drugs and/or fluid challenges within 6 hours prior to enrolment
• admitted to the neonatal intensive care unit
• premature birth with gestational age corrected for post-conceptional age less than 40 weeks
• congenital or acquired neuromuscular disorders
• congenital or acquired central nervous system disorders with depressed respiratory drive
• severe traumatic brain injury (i.e. Glasgow Coma Scale \< 8)
• congenital or acquired damage to the phrenic nerve
• congenital or acquired paralysis of the diaphragm
• use of neuromuscular blockade prior to enrolment
• uncorrected congenital heart disorder
• chronic lung disease
• severe pulmonary hypertension

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

Beatrix Children's Hospital, University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (2)

• Koopman AA, van Dijk J, Oppersma E, Blokpoel RGT, Kneyber MCJ. Surface electromyography to quantify neuro-respiratory drive and neuro-mechanical coupling in mechanically ventilated children. Respir Res. 2023 Mar 13;24(1):77. doi: 10.1186/s12931-023-02374-w.

  PMID: 36915106 DERIVED

• van Dijk J, Koopman AA, de Langen LB, Dijkstra S, Burgerhof JGM, Blokpoel RGT, Kneyber MCJ. Effect of pediatric ventilation weaning technique on work of breathing. Respir Res. 2022 Jul 13;23(1):184. doi: 10.1186/s12931-022-02106-6.

  PMID: 35831900 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD FCCM

Model Details: This is a prospective exploratory study with invasive measurements in a 20 bed tertiary paediatric intensive care facility at the Beatrix Children's Hospital/University Medical Centre Groningen.

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: November 29, 2017
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)