lancet-header
Preprints with The Lancet is part of SSRN´s First Look, a place where journals and other research experts identify content of interest prior to publication. These preprint papers are not peer-reviewed. Authors have either opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet, or submitted directly via SSRN. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These papers should not be used for clinical decision making or reporting of research to a lay audience without indicating that this is preliminary research that has not been peer-reviewed. For more information see the Comment published in The Lancet, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com

Nasal High Flow in Children with Acute Hypoxemic Respiratory Failure. A Paediatric Acute Respiratory Intervention Study (Paris)

52 Pages Posted: 23 Jun 2019

See all articles by Donna Franklin

Donna Franklin

Queensland Children's Hospital - Paediatric Critical Care Research Group; University of Queensland - School of Medicine; Queensland Children’s Hospital; University of Queensland - Mater Research Institute; Paediatric Research in Emergency Departments International Collaborative (PREDICT)

Deborah Shellshear

Queensland Children's Hospital - Paediatric Critical Care Research Group

Franz E. Babl

University of Melbourne - Department of Paediatrics; University of Melbourne - Emergency Department; Royal Childrens Hospital - Murdoch Childrens Research Institute

Rikki Hendrickson

Queensland Children’s Hospital

Amanda Williams

Paediatric Research in Emergency Departments International Collaborative (PREDICT)

Kristen Gibbons

Queensland Children's Hospital - Paediatric Critical Care Research Group

Kate McEnery

Queensland Children's Hospital - Paediatric Critical Care Research Group

Mel Kennedy

Queensland Children's Hospital - Paediatric Critical Care Research Group

Trang M. T. Pham

Queensland Children's Hospital - Paediatric Critical Care Research Group

Jason Acworth

University of Queensland - School of Medicine

David Levitt

Queensland Children’s Hospital

Ed Oakley

Paediatric Research in Emergency Departments International Collaborative (PREDICT)

Andreas Schibler

Queensland Children's Hospital - Paediatric Critical Care Research Group

PARIS and PREDICT

More...

Abstract

Background: High-flow oxygen-therapy is increasingly used in children with acute hypoxic respiratory failure (AHRF), despite limited high-quality evidence of efficacy outside intensive care units.

Methods: An open labelled RCT feasibility design was used in emergency departments and general wards of two tertiary children's hospitals. Over a period of 1-year, children aged 0-16 years with AHRF were randomised (1:1) to either high-flow or standard-oxygen. Children on the standard-oxygen could receive rescue high-flow in the general wards if their conditions met treatment failure criteria. The primary efficiency-endpoints were feasibility, recruitment rates and safety followed by the efficacy-endpoints measuring the proportion escalation of care. We measured the duration of hospital stay, duration of oxygen therapy and rates of ICU admission.

Findings: Of 563 randomised, 283 received high-flow and 280 standard-oxygen with no adverse events. The proportion of children receiving escalation of care was 11.7% (32/283 children) on the high-flow and 18.1% (50/280 infants) on standard-oxygen (risk difference -6.4 percentage points; 95% CI -12.4%, -0.5%; p=0.04). In children with obstructive airway disease 9.7% on high-flow and 17.4% on standard-oxygen required escalation (risk difference -7.7% percentage points; 95% CI -14.3%, -1.1%; p=0.03), whereas in children with non-obstructive disease no difference was observed. No difference in length of hospital stay was observed. 40% of children who failed standard-oxygen responded to rescue high-flow.

Interpretation: High-flow outside ICU appears to be safe in children with AHRF and the required proportion of escalation was lower compared to standard-oxygen. The trial design can be applied in a future large RCT.

Trial Registration: The study protocol was registered with the Australian and New Zealand Clinical Trials Registry. (ACTRN12615001305516).

Funding Statement: The study was supported by a grant provided by Thrasher Research Fund and a project grant provided by the National Health and Medical Research Council.

The high-flow equipment and consumables for both trial sites were donated by Fisher & Paykel Healthcare, which had no involvement in the design and conduct of the trial, the analysis of the data, or in the preparation of the manuscript.

Declaration of Interests: DF and AS report financial support for travel and accommodation provided by Fisher&Paykel Healthcare, Auckland, New Zealand

Ethics Approval Statement: The study was approved by Children’s Health Queensland Human Research Ethics Committee (HREC/15/QRCH/159) and the authors used a consent to continue process.

Keywords: Paediatrics, Oxygen saturation, Respiratory Distress, Reactive Airways Disease, Acute respiratory failure

Suggested Citation

Franklin, Donna and Shellshear, Deborah and Babl, Franz and Hendrickson, Rikki and Williams, Amanda and Gibbons, Kristen and McEnery, Kate and Kennedy, Mel and Pham, Trang M. T. and Acworth, Jason and Levitt, David and Oakley, Ed and Schibler, Andreas and PREDICT, PARIS and, Nasal High Flow in Children with Acute Hypoxemic Respiratory Failure. A Paediatric Acute Respiratory Intervention Study (Paris) (June 17, 2019). Available at SSRN: https://ssrn.com/abstract=3405600 or http://dx.doi.org/10.2139/ssrn.3405600

Donna Franklin (Contact Author)

Queensland Children's Hospital - Paediatric Critical Care Research Group ( email )

Brisbane
Australia

University of Queensland - School of Medicine ( email )

St Lucia
Queensland 4072
Australia

Queensland Children’s Hospital ( email )

Brisbane
Australia

University of Queensland - Mater Research Institute ( email )

Brisbane
Australia

Paediatric Research in Emergency Departments International Collaborative (PREDICT) ( email )

Parkville, Victoria
Australia

Deborah Shellshear

Queensland Children's Hospital - Paediatric Critical Care Research Group

Brisbane
Australia

Franz Babl

University of Melbourne - Department of Paediatrics

Australia

University of Melbourne - Emergency Department

Australia

Royal Childrens Hospital - Murdoch Childrens Research Institute

Parkville, Victoria
Australia

Rikki Hendrickson

Queensland Children’s Hospital

Brisbane
Australia

Amanda Williams

Paediatric Research in Emergency Departments International Collaborative (PREDICT)

Parkville, Victoria
Australia

Kristen Gibbons

Queensland Children's Hospital - Paediatric Critical Care Research Group

Brisbane
Australia

Kate McEnery

Queensland Children's Hospital - Paediatric Critical Care Research Group

Brisbane
Australia

Mel Kennedy

Queensland Children's Hospital - Paediatric Critical Care Research Group

Brisbane
Australia

Trang M. T. Pham

Queensland Children's Hospital - Paediatric Critical Care Research Group

Brisbane
Australia

Jason Acworth

University of Queensland - School of Medicine

St Lucia
Queensland 4072
Australia

David Levitt

Queensland Children’s Hospital

Brisbane
Australia

Ed Oakley

Paediatric Research in Emergency Departments International Collaborative (PREDICT)

Parkville, Victoria
Australia

Andreas Schibler

Queensland Children's Hospital - Paediatric Critical Care Research Group

Brisbane
Australia

No contact information is available for PARIS and PREDICT

Click here to go to TheLancet.com

Paper statistics

Abstract Views
220
Downloads
38