O2 Tension During TAVI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-18

Study Completion Date

2022-07-18

Brief Summary

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Hyperoxemia can produce various complications including oxidative stress and myocardial injury. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after transcatheter aortic valve replacement.

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Detailed Description

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Hyperoxemia can produce various complications, such as excessive oxidative stress, hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant myocardial injury. Previous studies have been observed higher mortality in patient group maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after TAVR.

Conditions

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Troponin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Normoxemia

Patients randomized to the normoxemia group receives inspired oxygen fraction of 0.3 from initiation of induction of anesthesia to the end of the procedure.

Group Type EXPERIMENTAL

normal inspired oxygen fraction

Intervention Type OTHER

receives inspired oxygen fraction of 0.3

Hyperoxemia

Patients randomized to the hyperoxemia group receives inspired oxygen fraction of 0.8 from initiation of induction of anesthesia to the end of the procedure.

Group Type ACTIVE_COMPARATOR

high inspired oxygen fraction

Intervention Type OTHER

receives inspired oxygen fraction of 0.8

Interventions

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normal inspired oxygen fraction

receives inspired oxygen fraction of 0.3

Intervention Type OTHER

high inspired oxygen fraction

receives inspired oxygen fraction of 0.8

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Scheduled for transcatheter aortic valve replacement due to aortic stenosis

Exclusion Criteria

* Transapical approach
* Pre-procedural PaO2 \< 65 mmHg or oxygen support therapy
* Pre-procedural severe kidney injury (end-stage renal disease)
* Pre-procedural chronic pulmonary disease, symptomatic asthma
* Pre-procedural Tb-destroyed lung
* Lung cancer
* History of acute coronary syndrome within 6 months
* Pre-procedural elevated Troponin I or CKMB
* History of stroke or transient ischemic attack within 6 months
* Refuse to participate
* Pregnant

Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No