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. 2024 Nov 6;25(1):741.
doi: 10.1186/s13063-024-08538-3.

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: update to the statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial

Sarah N Dawson  1   2 , Yi-Da Chiu  3 , Andrew A Klein  4 , Melissa Earwaker  5 , Sofia S Villar  6 ; NOTACS study team
Collaborators, Affiliations

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: update to the statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial

Sarah N Dawson et al. Trials. .

Abstract

Background: The NOTACS trial will assess the efficacy, safety and cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard oxygen therapy (SOT) on the outcomes of patients after cardiac surgery.

Methods/design: NOTACS is an adaptive, international, multicentre, parallel group, randomised controlled trial, with a pre-planned interim sample size re-estimation (SSR). A minimum of 850 patients will be randomised 1:1 to receive either HFNT or SOT. The primary outcome is days alive and at home in the first 90 days after the planned surgery (DAH90), with a number of secondary analyses and cost-effectiveness analyses also planned. The interim SSR will take place after a minimum of 300 patients have been followed up for 90 days and will allow for the sample size to increase up to a maximum of 1280 patients.

Results: This manuscript provides detailed descriptions of the design of the NOTACS trial and the analyses to be undertaken at the interim and final analyses. The main purpose of the interim analysis is to assess safety and to perform a sample size re-estimation. The main purpose of the final analysis is to examine the safety, efficacy and cost-effectiveness of HFNT compared to SOT on the outcomes of patients after cardiac surgery.

Discussion: This manuscript outlines the key features of the NOTACS statistical analysis plan and was submitted to the journal before the final analysis in order to preserve scientific integrity under an adaptive design framework. A previous version of this SAP was published prior to the interim analysis (Dawson, 2022). The NOTACS SAP closely follows published guidelines for the content of SAPs in clinical trials (Gamble, 2017).

Trial registration: ISRCTN14092678 . (13 May 2020).

Keywords: Adaptive design; Sample size re-estimation; Statistical analysis plan.

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Conflict of interest statement

A free of charge loan agreement between Royal Papworth Hospital NHS Foundation Trust and Fisher & Paykel for all AIRVO 2 HFNT devices and consumable needed for the completion of the study has been made. Fisher & Paykel however have not contributed to the study design or protocol and SAP development.

AK or his institution has received unrestricted educational grant funding, honoraria or travel funding from Fisher and Paykel, Pharmacosmos, Masimo, Haemonetics and Nordic.

References

    1. Alex Dmitrienko PA. Multiplicity considerations in clinical trials. N Engl J Med. 2018;378:2115–22. 10.1056/NEJMra1709701. - DOI - PubMed
    1. Carrol Gamble AK. Guidelines for the content of statistical analysis plans in clinical trials. 2017;318(23):2337–43. 10.1001/jama.2017.18556. - DOI - PubMed
    1. Cuquemelle ELF. Assessment of humidification performance: still no easy method!. 2013;58(9):1559–1561. 10.4187/respcare.02761. - PubMed
    1. Dawson SC. Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial. Trials. 2022;699. 10.1186/s13063-022-06607-z. - PMC - PubMed
    1. Jabbari AAE. Clinical usage of high-flow oxygenation in postcardiac surgery patients. 2019; 22(1):107–108. 10.4103/aca.ACA_7_18. - PMC - PubMed

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