A study to compare two methods of oxygen delivery during transcatheter aortic valve implantation (TAVI)

A randomised controlled trial of high-flow nasal oxygen (HFNO) vs standard oxygen therapy in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) under conscious sedation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13804861

Enrollment

Registered

2019-04-30

Start date

2019-05-01

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen supply during transcatheter aortic valve implantation (TAVI) Surgery

Interventions

Screening and consent: Patients scheduled to undergo a TAVI procedure will be identified by a member of the study team. Patients meeting the entry criteria will be provided with a patient information

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Able to provide informed consent 2. Adult patients (> 18 years) 3. Patients undergoing an elective transfemoral TAVI procedure

Exclusion criteria

Exclusion criteria: 1. Contraindication to HFNO such as a nasal septum defect 2. Participation in another randomised controlled trial

Design outcomes

Primary

Measure	Time frame
The partial pressure of oxygen dissolved in the blood (PaO2) taken from an arterial blood gas sample during the procedure	—

Secondary

Measure	Time frame
1. The number of desaturations (defined as SpO2 10 seconds or SpO2 drop more than 5% from baseline for >10 seconds) at any time during the procedure measured by pulse oximetry 2. Time spent on the Recovery ward post-procedure measured in hours 3. Number of patients requiring conversion to general anaesthesia during the procedure 4. Duration of oxygen provision during and post-procedure measured in hours 5. Patient-reported comfort measured using the Patient Comfort Questionnaire post-procedure 6. Time spent in hospital measured in days at discharge	—

Measure

Time frame

1. The number of desaturations (defined as SpO2 10 seconds or SpO2 drop more than 5% from baseline for >10 seconds) at any time during the procedure measured by pulse oximetry 2. Time spent on the Recovery ward post-procedure measured in hours 3. Number of patients requiring conversion to general anaesthesia during the procedure 4. Duration of oxygen provision during and post-procedure measured in hours 5. Patient-reported comfort measured using the Patient Comfort Questionnaire post-procedure 6. Time spent in hospital measured in days at discharge

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026