TY - JOUR
T1 - Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery
T2 - a study protocol for a multicentre adaptive randomised controlled trial
AU - Earwaker, Melissa
AU - Villar, Sofia
AU - Fox-Rushby, Julia
AU - Duckworth, Melissa
AU - Dawson, Sarah
AU - Steele, Jo
AU - Chiu, Yi da
AU - Litton, Edward
AU - Kunst, Gudrun
AU - Murphy, Gavin
AU - Martinez, Guillermo
AU - Zochios, Vasileios
AU - Brown, Val
AU - Brown, Geoff
AU - Klein, Andrew
N1 - Funding Information:
AK or his institution has received unrestricted educational grant funding, honoraria or travel funding from Fisher and Paykel, Pharmacosmos, Masimo, Haemonetics and Nordic.
Funding Information:
Australian recruitment is funded by the Medical Research Future Fund (MRFF, APP2006100).
Funding Information:
This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment, Unique Award Identifier: NIHR128351. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: High-flow nasal therapy is a non-invasive form of respiratory support that delivers low-level, flow dependent positive airway pressure. The device can be better tolerated by patients than alternatives such as continuous positive airway pressure. The primary objective is to determine if prophylactic high-flow nasal therapy after tracheal extubation can result in an increase in the number of days alive and at home within the first 90 days after surgery, when compared with standard oxygen therapy. The co-primary objective is to estimate the incremental cost-effectiveness and cost-utility of high-flow nasal therapy vs standard oxygen therapy at 90 days, from the view-point of the public sector, the health service and patients. Methods: This is an adaptive, multicentre, international parallel-group, randomised controlled trial with embedded cost-effectiveness analysis comparing the use of high-flow nasal therapy with control in patients at high risk of respiratory complications following cardiac surgery. Participants will be randomised before tracheal extubation and allocated either high-flow nasal therapy or standard oxygen therapy for a minimum of 16 h immediately post extubation. Participants will be followed up until 90 days after surgery. The total sample size needed to detect a 2-day increase in DAH90 with 90% power with an intention to treat analysis is 850 patients. The adaptive design includes an interim sample size re-estimation which will provide protection against deviations from the original sample size assumptions made from the single-centre pilot study and will allow for a maximum sample size increase to 1152 patients. Discussion: Evidence to support routine use of high-flow nasal therapy will inform the development of effective enhanced recovery care bundles. Reducing complications should reduce length of stay and re-admission to hospital and provide an important focus for cost reduction. However; high-quality studies evaluating the clinical and cost effectiveness of high-flow nasal therapy after cardiothoracic surgery are lacking. Trial registration: The study has been registered with ISRCTN (ISRCTN14092678, 13/05/2020) Clinicaltrials.gov Registration Pending
AB - Background: High-flow nasal therapy is a non-invasive form of respiratory support that delivers low-level, flow dependent positive airway pressure. The device can be better tolerated by patients than alternatives such as continuous positive airway pressure. The primary objective is to determine if prophylactic high-flow nasal therapy after tracheal extubation can result in an increase in the number of days alive and at home within the first 90 days after surgery, when compared with standard oxygen therapy. The co-primary objective is to estimate the incremental cost-effectiveness and cost-utility of high-flow nasal therapy vs standard oxygen therapy at 90 days, from the view-point of the public sector, the health service and patients. Methods: This is an adaptive, multicentre, international parallel-group, randomised controlled trial with embedded cost-effectiveness analysis comparing the use of high-flow nasal therapy with control in patients at high risk of respiratory complications following cardiac surgery. Participants will be randomised before tracheal extubation and allocated either high-flow nasal therapy or standard oxygen therapy for a minimum of 16 h immediately post extubation. Participants will be followed up until 90 days after surgery. The total sample size needed to detect a 2-day increase in DAH90 with 90% power with an intention to treat analysis is 850 patients. The adaptive design includes an interim sample size re-estimation which will provide protection against deviations from the original sample size assumptions made from the single-centre pilot study and will allow for a maximum sample size increase to 1152 patients. Discussion: Evidence to support routine use of high-flow nasal therapy will inform the development of effective enhanced recovery care bundles. Reducing complications should reduce length of stay and re-admission to hospital and provide an important focus for cost reduction. However; high-quality studies evaluating the clinical and cost effectiveness of high-flow nasal therapy after cardiothoracic surgery are lacking. Trial registration: The study has been registered with ISRCTN (ISRCTN14092678, 13/05/2020) Clinicaltrials.gov Registration Pending
KW - Adaptive design
KW - Cardiothoracic surgery
KW - High-flow nasal therapy
KW - Post-operative pulmonary complications
UR - http://www.scopus.com/inward/record.url?scp=85127288569&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06180-5
DO - 10.1186/s13063-022-06180-5
M3 - Article
C2 - 35346339
AN - SCOPUS:85127288569
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 232
ER -