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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Critic

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 Summary:

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
Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Current Primary Outcome:

  • Number of eligible patients in Group A (step-up) and Group B (step-down) [ Time Frame: Baseline ]
  • Number of parents/guardians who refuse prospective or deferred consent [ Time Frame: Through study completion, an average of 24 hours ]
  • Randomising at least 50% of eligible patients [ Time Frame: Baseline ]
  • Proportion of patients adherent to the study treatment [ Time Frame: Through study completion, an average of 72 hours ]
  • Mean COMFORT score [ Time Frame: 72 hours ]
  • Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU) [ Time Frame: 24 hours ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of children randomised to the intervention or control who need intubation (Group A) or re-intubation (Group B) [ Time Frame: 72 hours ]
  • 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 ]
  • 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 [ Time Frame: 28 days ]
  • Improvement in oxygenation, partial pressure of carbon dioxide (pCO2) levels, heart rate, respiratory rate, and work of breathing [ Time Frame: 24 hours ]
  • 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 ]
  • Mortality at PICU discharge and at hospital discharge [ Time Frame: through study completion, an average of 28 days ]


Original Secondary Outcome: Same as current

Information By: Great Ormond Street Hospital for Children NHS Foundation Trust

Dates:
Date Received: October 23, 2015
Date Started: November 2015
Date Completion:
Last Updated: December 15, 2016
Last Verified: December 2016