FIRST-line Support for Assistance in Breathing in Children (FIRST-ABC) Feasibility Study

Hypoxia Clinical Trial

— FIRST-ABC  

Official title:

FIRST-ABC Feasibility Study: Feasibility Study for a Randomised Trial of High Flow Nasal Cannula (HFNC) Versus Continuous Positive Airway Pressure (CPAP) for Non-invasive Respiratory Support in Critically Ill Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612415
• Other study ID #: 14HC30
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 23, 2015
• Last updated: December 15, 2016
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A feasibility study to inform the design and conduct of a randomised controlled trial of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in critically ill children

Description:

Breathing support is the most common intervention provided to critically ill children in a paediatric intensive care unit (PICU). Although invasive breathing support (delivered through a tracheal tube) is lifesaving, concerns regarding its risks (infection and lung damage) have prompted greater use of non-invasive respiratory support (NRS). However, there is little scientific evidence to guide PICU clinicians on the comparative effectiveness of the commonly used modes of NRS.

In this feasibility study, the investigators are testing whether it is possible to conduct a randomised clinical trial comparing two modes of NRS: continuous positive airway pressure (CPAP), which has been used for over two decades, and high flow nasal cannula (HFNC), a newer method of respiratory support. It is not known for sure how useful HFNC is in critically ill children because there is no published research comparing it with CPAP. However, since HFNC is easier to use and better tolerated by children, many hospitals are now using HFNC instead of CPAP. Before HFNC is widely adopted, a clinical trial to establish its role in the management of critically ill children is urgently needed.

As part of this study, the investigators will randomly allocate children deemed to require NRS by their treating clinician to either HFNC or CPAP. The investigators will mainly assess whether sufficient number of children can be recruited to the trial, whether clinicians are willing to randomise children, and test the proposed treatment pathways for CPAP and HFNC. The trial will run over six months, and recruit 120 sick children from three National Health Service (NHS) hospitals. Consent will be sought from parents/guardians for their children to be included in the study, usually before CPAP or HFNC is started, unless emergency life-saving treatment is required, in which case consent will be deferred until there is more time to discuss the study with parents/guardians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Weeks to 15 Years

Eligibility

Inclusion Criteria:

Eligible patients will fall into one of two groups:

Group A (Step-up)

1. Age >36 weeks corrected gestational age and <16 years, AND

2. Deemed to require non-invasive respiratory support by the treating clinician for an acute illness, AND

3. Satisfies one or more of the following criteria:

• Hypoxia (oxygen saturation <92% in fraction of inspired oxygen (FiO2) >0.40, or equivalent). FiO2 of 0.40 roughly equates to standard unhumidified nasal cannula oxygen delivered at 6 L/min or oxygen delivered via facemask without a rebreather bag at 6-10 L/min.

• Acute respiratory acidosis (pH <7.3 with a concomitant pCO2 >6.5 kPa)

• Moderate respiratory distress (use of accessory muscles, subcostal and intercostal recession, tachypnoea for age, grunting)

Group B (Step-down)

1. Age >36 weeks corrected for gestation and <16 years, AND

2. Deemed to require non-invasive respiratory support by the treating clinician after extubation, following a spell of invasive ventilation

• Either immediately after extubation as a 'planned' procedure, irrespective of clinical condition ('planned') OR

• Prompted by deterioration in clinical condition within 72 hours after extubation ('rescue'). Clinical parameters to assess the need for NRS in this situation will be similar to point 3 in Group A.

Exclusion Criteria:

1. Deemed by the treating clinician to require immediate intubation/invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction or recurrent apnoeas

2. Tracheostomy in place

3. Pre-existing air-leak syndrome (pneumothorax/pneumomediastinum)

4. Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or had recent craniofacial surgery

5. Agreed limitation of intensive care treatment plan in place ('not for intubation')

6. On domiciliary non-invasive ventilation prior to PICU admission

7. Managed on either HFNC and/or CPAP (or other form of non-invasive ventilation such as BiPAP) in the preceding 24 hours

8. Previously recruited to this study during the same PICU admission

9. Cannot be treated with HFNC

• Unavailability of appropriate sized nasal prongs

• Unavailability of HFNC device

10. Cannot be treated with CPAP

• Unavailability of right size of face mask, prong or other patient interface

• Unavailability of CPAP device

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acidosis
• Hypoxia
• Moderate/Severe Respiratory Distress
• Respiratory Acidosis

Intervention

Device:
• Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula
A heated, humidified, HFNC device will be used to deliver a gas flow rate of 2 L/kg/min for the duration that the patient needs non-invasive respiratory support
• Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure
CPAP will be provided using a set expiratory pressure of 6-8 cm water (H2O) pressure for the duration that the infant needs non-invasive respiratory support

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (4)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust	Barts & The London NHS Trust, Imperial College London, Intensive Care National Audit & Research Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eligible patients in Group A (step-up) and Group B (step-down)		Baseline	No
Primary	Number of parents/guardians who refuse prospective or deferred consent		Through study completion, an average of 24 hours	No
Primary	Randomising at least 50% of eligible patients		Baseline	No
Primary	Proportion of patients adherent to the study treatment		Through study completion, an average of 72 hours	No
Primary	Mean COMFORT score		72 hours	No
Primary	Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU)		24 hours	No
Secondary	Proportion of children randomised to the intervention or control who need intubation (Group A) or re-intubation (Group B)		72 hours	No
Secondary	Proportion of children randomised to the intervention or control who fail the assigned treatment and require either crossover or escalation to other forms of ventilation		72 hours	No
Secondary	Number of children who experience pre-specified adverse events (pneumothorax, pneumomediastinum, nasal or facial trauma, abdominal distension, nosocomial infection) during the period they are receiving non-invasive respiratory support		28 days	Yes
Secondary	Improvement in oxygenation, partial pressure of carbon dioxide (pCO2) levels, heart rate, respiratory rate, and work of breathing		24 hours	No
Secondary	Length of PICU and hospital stay, length of invasive ventilation, length of non-invasive support, ventilator-free days at day 28		through study completion, an average of 28 days	No
Secondary	Mortality at PICU discharge and at hospital discharge		through study completion, an average of 28 days	No