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High-flow nasal oxygen (HFNO) vs standard oxygen therapy in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI)

Not Applicable
Conditions
Aortic valve disease
Aortic valve stenosis
Transfemoral transcatheter aortic valve implantation
Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system
Registration Number
ACTRN12621001080819
Lead Sponsor
The Alfred
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

Inclusion Criteria
•Informed consent available;
•Adult patients (> 18 years) with signed informed consent with body mass index greater than or equal to 35 kg/m2;
•Elective TAVI procedure; and
•Patients capable of performing a walk test and spirometry

Exclusion Criteria

Exclusion Criteria
•No informed consent available;
•Contraindication to HFNO such as nasal septal defect;
•Uncooperative patient; and
•Need for intubation / conversion to GA during procedure.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The partial pressure of oxygen dissolved in the blood (PaO2) taken from an arterial blood gas sample during the procedure[ABG will be taken every 20 minutes or as determined by clinical need]
Secondary Outcome Measures
NameTimeMethod
The number of desaturations (defined as SpO2 <93% for >10 seconds or SpO2 drop more than 5% from baseline for >10 seconds) at any time during the procedure measured by pulse oximetry.[Duration of the procedure. ];Time spent on the Recovery ward post-procedure measured in hours as taken from medical record[Patients Recovery stay. ];Conversion to general anaesthesia during the procedure as taken from medical record or recorded real time intraoperatively[This will be assessed during the procedure when the decision for conversion to GA is made by the treating doctors. ];Duration of oxygen provision during and post-procedure measured in hours as taken from medical record[Duration of study. ];Time spent in hospital measured in days at discharge as taken from medical record[At hospital discharge];Patient satisfaction[Follow up questioning regarding overall comfort level, respiratory tract dryness, stomach bloating will be assessed prior to discharge, ]
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