NCT05308719

Nasal Oxygen Therapy After Cardiac Surgery

Effect of High-Flow Nasal Therapy on Patient-Centered Outcomes in Patients at High Risk of Postoperative Pulmonary Complications After Cardiac Surgery: A Multicentre Randomised Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,280 (actual)
• Sponsor: Papworth Hospital NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

NOTACS aims to determine if prophylactic use of high-flow nasal therapy (for a minimum of 16 hours after tracheal extubation, inclusive of up to one hour off randomised therapy for transfers around the hospital and/or physio mobilisation) increases days at home in the first 90 days after surgery, for adult patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications. The study also incorporates a health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy at 90 days, from the view-point of the public sector, NHS and patients.

Detailed description

Patients undergoing cardiac surgery are at significant risk of postoperative pulmonary complications that may lead to prolonged ICU and hospital stay and increase mortality. The incidence of respiratory complications may be three to four times more common in patients with intrinsic respiratory disease and lower airway obstruction (including asthma or chronic obstructive pulmonary disease (COPD)), or obese patients or current heavy smokers (\> 10 pack years). High-flow nasal therapy (HFNT) is increasingly used as a non-invasive form of respiratory support. It delivers low level, flow-dependent positive airway pressure, and is much better tolerated by patients than alternatives such as continuous positive airway pressure (CPAP) or non-invasive ventilation. Patients can talk, eat, drink and walk whilst using HFNT. However, there is equipoise regarding its prophylactic use and effect on important patient-centred outcomes. Before the intervention is recommended for routine NHS use in cardiac surgery patients at high risk of pulmonary complications, whether it improves patient-related outcomes and is cost effective in a UK setting needs to be assessed.

Conditions

• Cardiac Valve Disease
• Coronary Artery Disease
• Respiratory Failure

Interventions

Type	Name	Description
DEVICE	High Flow Nasal Therapy	High Flow Nasal Oxygen (Airvo2 Device)

Timeline

• Start date: 2020-09-08
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2022-04-04
• Last updated: 2025-05-29

Locations

1 site across 1 country: United Kingdom