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

Primary Purpose

Hypoxia, Respiratory Acidosis, Moderate/Severe Respiratory Distress

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula

Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure

About this trial

This is an interventional treatment trial for Hypoxia

Eligibility Criteria

36 Weeks - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligible patients will fall into one of two groups:

Group A (Step-up)

Age >36 weeks corrected gestational age and <16 years, AND
Deemed to require non-invasive respiratory support by the treating clinician for an acute illness, AND
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)

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

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
Tracheostomy in place
Pre-existing air-leak syndrome (pneumothorax/pneumomediastinum)
Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or had recent craniofacial surgery
Agreed limitation of intensive care treatment plan in place ('not for intubation')
On domiciliary non-invasive ventilation prior to PICU admission
Managed on either HFNC and/or CPAP (or other form of non-invasive ventilation such as BiPAP) in the preceding 24 hours
Previously recruited to this study during the same PICU admission
Cannot be treated with HFNC
- Unavailability of appropriate sized nasal prongs
- Unavailability of HFNC device
Cannot be treated with CPAP
- Unavailability of right size of face mask, prong or other patient interface
- Unavailability of CPAP device

Sites / Locations

Barts Health NHS Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flow nasal cannula (HFNC)

Continuous positive airway pressure (CPAP)

Arm Description

Heated humidified high flow nasal cannula therapy delivered at 2 L/kg/min gas flow rate (for children older than 10 kg in weight, an additional 0.5 L/kg/min per kilogram over 10 kg). Any approved device can be used to deliver HFNC

Continuous positive airway pressure delivered using any interface (hood, mask or prongs)

Outcomes

Primary Outcome Measures

Number of eligible patients in Group A (step-up) and Group B (step-down)

Number of parents/guardians who refuse prospective or deferred consent

Randomising at least 50% of eligible patients

Proportion of patients adherent to the study treatment

Mean COMFORT score

Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU)

Secondary Outcome Measures

Proportion of children randomised to the intervention or control who need intubation (Group A) or re-intubation (Group B)

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

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

Improvement in oxygenation, partial pressure of carbon dioxide (pCO2) levels, heart rate, respiratory rate, and work of breathing

Length of PICU and hospital stay, length of invasive ventilation, length of non-invasive support, ventilator-free days at day 28

Mortality at PICU discharge and at hospital discharge

Full Information

NCT ID

NCT02612415

First Posted

October 23, 2015

Last Updated

December 15, 2016

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborators

Imperial College London, Barts & The London NHS Trust, Intensive Care National Audit & Research Centre

1. Study Identification

Unique Protocol Identification Number

NCT02612415

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborators

Imperial College London, Barts & The London NHS Trust, Intensive Care National Audit & Research Centre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxia, Respiratory Acidosis, Moderate/Severe Respiratory Distress

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High flow nasal cannula (HFNC)

Arm Type

Experimental

Arm Description

Arm Title

Continuous positive airway pressure (CPAP)

Arm Type

Active Comparator

Arm Description

Continuous positive airway pressure delivered using any interface (hood, mask or prongs)

Intervention Type

Device

Intervention Name(s)

Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of eligible patients in Group A (step-up) and Group B (step-down)

Time Frame

Baseline

Title

Number of parents/guardians who refuse prospective or deferred consent

Time Frame

Through study completion, an average of 24 hours

Title

Randomising at least 50% of eligible patients

Time Frame

Baseline

Title

Proportion of patients adherent to the study treatment

Time Frame

Through study completion, an average of 72 hours

Title

Mean COMFORT score

Time Frame

72 hours

Title

Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU)

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Proportion of children randomised to the intervention or control who need intubation (Group A) or re-intubation (Group B)

Time Frame

72 hours

Title

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

Time Frame

72 hours

Title

Time Frame

28 days

Title

Improvement in oxygenation, partial pressure of carbon dioxide (pCO2) levels, heart rate, respiratory rate, and work of breathing

Time Frame

24 hours

Title

Length of PICU and hospital stay, length of invasive ventilation, length of non-invasive support, ventilator-free days at day 28

Time Frame

through study completion, an average of 28 days

Title

Mortality at PICU discharge and at hospital discharge

Time Frame

through study completion, an average of 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

36 Weeks

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligible patients will fall into one of two groups: Group A (Step-up) Age >36 weeks corrected gestational age and <16 years, AND Deemed to require non-invasive respiratory support by the treating clinician for an acute illness, AND 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) Age >36 weeks corrected for gestation and <16 years, AND 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: 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 Tracheostomy in place Pre-existing air-leak syndrome (pneumothorax/pneumomediastinum) Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or had recent craniofacial surgery Agreed limitation of intensive care treatment plan in place ('not for intubation') On domiciliary non-invasive ventilation prior to PICU admission Managed on either HFNC and/or CPAP (or other form of non-invasive ventilation such as BiPAP) in the preceding 24 hours Previously recruited to this study during the same PICU admission Cannot be treated with HFNC Unavailability of appropriate sized nasal prongs Unavailability of HFNC device Cannot be treated with CPAP Unavailability of right size of face mask, prong or other patient interface Unavailability of CPAP device

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Padmanabhan Ramnarayan

Organizational Affiliation

Consultant in Paediatric Intensive Care & Retrieval Children's Acute Transport Service (CATS)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barts Health NHS Trust

City

London

Country

United Kingdom

Facility Name

Great Ormond Street Hospital for Children NHS Foundation Trust

City

London

Country

United Kingdom

Facility Name

Imperial College Healthcare NHS Trust

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29866165

Citation

Ramnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter RR, Wulff J, Harrison DA, Mouncey PM, Peters MJ; United Kingdom Paediatric Intensive Care Society Study Group (PICS-SG). FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care. Crit Care. 2018 Jun 4;22(1):144. doi: 10.1186/s13054-018-2080-3.

Results Reference

derived

PubMed Identifier

28606907

Citation

Ramnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter R, Mouncey P, Peters MJ. FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children. BMJ Open. 2017 Jun 12;7(6):e016181. doi: 10.1136/bmjopen-2017-016181.

Results Reference

derived

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

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