Paediatric Ards Neuromuscular Blockade Study (PAN)

STATUS

Recruiting
End date

May 1, 2024
participants needed

178
sponsor

University Medical Center Groningen

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Updated on 21 February 2022

See if I qualify

mechanical ventilation

fluid overload

chest radiograph

acute respiratory distress

positive end expiratory pressure

neuromuscular blocking agents

ventilator-induced lung injury

assisted breathing

Summary

Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe, life-threatening lung injury. Care for paediatric patient is mainly supportive and based on what works in adults and personal experiences, including the use of mechanical ventilation. However, differences in lung physiology and immunology between (young) children and adults suggests that adaptation of adult practices into paediatrics may not be justified. A study in adults with severe ARDS showed that early use of neuromuscular blocking agents (NMBA) improved 90-day survival and increased time off the ventilator without increasing muscle weakness. It is unknown if this is also true for paediatric ARDS

Details

Condition	ARDS
Treatment	Isotonic saline, Neuromuscular blocking agents
Clinical Study Identifier	NCT02902055
Sponsor	University Medical Center Groningen
Last Modified on	21 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Informed consent
	Age younger than 5 years
	Need for mechanical ventilation with tidal volume 5 - 8 mL/kg ideal bodyweight and PEEP equal to or greater than 5 cmH2O
	Early moderate - to - severe paediatric acute respiratory distress syndrome originating from any cause, i.e. acute onset of disease, and oxygenation index greater than 12, and one or more (bilateral) infiltrates on chest radiograph, and no evidence of left ventricular failure or fluid overload, and within the first 48 hours of PICU admission
	Sedation defined by Comfort - B scale between 9 - 12
Exclusion Criteria
	No informed consent
	Known allergy or intolerance to rocuronium
	Continuous administration of neuromuscular blockade prior at the time of meeting the criteria for PARDS
	Chronic respiratory failure on home ventilation
	Intracranial hypertension
	Bone marrow transplantation
	Immunocompromised patients (congenital or acquired)
	Pre-existing pulmonary hypertension
	Congenital heart disease with left - to - right shunting
	Cyanotic congenital heart disease
	Expected duration of mechanical ventilation less than 48 hours
	Withdrawal of life - sustaining treatment

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mechanical ventilation

fluid overload

chest radiograph

acute respiratory distress

positive end expiratory pressure

neuromuscular blocking agents

ventilator-induced lung injury

assisted breathing

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Paediatric Ards Neuromuscular Blockade Study (PAN)