Feasibility and Efficacy of Nasal High Flow in Children post Extubation - Pilot phase study

Not Applicable

Completed

• Conditions: Airway management; Post extubation respiratory support; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621001678886
• Lead Sponsor: Gold Coast Hospital and Health Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-08
• Study Completion: 2022-05-23
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Inclusion Criteria for Moderate Reintubation Risk Group (MRRG)- General ICU study

All children less than 16 years of age with parental consent and one or both of the following:
•length of mechanical ventilation equal or more than 4 days
•oxygen requirement (FiO2 equal or more than 0.4) at extubation

Inclusion Criteria for Moderate Reintubation Risk Group (MRRG) - Cardiac ICU study

All children less than 16 years of age with parental consent and one or more of the following:
•RACHS equal or less than4
•all neonates post cardio-pulmonary bypass and age equal or less than 42 days (post cardiac surgery patients only) belong into MRRG
•oxygen requirement (FiO2 equal or more than 0.4) at extubation

Inclusion Criteria for Low Reintubation Risk Group (LRRG) – General ICU AND Cardiac ICU studies

All children less than 16 years of age with parental consent, who fail standard oxygen therapy and require escalation of respiratory support within the first 72 hours post extubation and one or more of the following:
•all children who do not meet either the inclusion criteria for the moderate-risk reintubation group or meet one of the exclusion criteria
•length of mechanical ventilation less than 4 days
•oxygen requirement prior at extubation (FiO2 less than 0.4)

Exclusion Criteria

Excluded are children who require a specific respiratory support (high-risk) or are excluded with the following conditions:
•Severe cardiac failure
•Child on home respiratory support
•Craniofacial abnormalities preventing the use of NHF or CPAP
•Underlying pathology requiring CPAP or BIPAP such as severe tracheomalacia or bronchomalacia
•Upper gastrointestinal surgery where positive airway pressure is contraindicated
•Acknowledged and agreed limitations to care (e.g., do not intubate or resuscitate) or death imminent
•Epistaxis
•Mid-facial fracture
•Previously recruited in the same trial during the same ICU admission
•RACHS 5 and 6
•Neuromuscular conditions
•Choanal atresia/severe choanal stenosis
•Anatomical or acquired airway conditions with a specific airway and respiratory management protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified