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临床试验/NCT07688941
NCT07688941尚未招募不适用

Evaluation of the Relationship Between Preoperative Cardiopulmonary Performance Indicators (Hand Grip Strength and 6-Minute Walk Test) and Preoxygenation and Oxygen Reserve

Ankara City Hospital Bilkent0 个研究点目标入组 120 人开始时间: 2026年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Preoxygenation Efficiency (EtO_2 Time)

研究概览

简要总结

The goal of this observational study is to evaluate the relationship between preoperative cardiopulmonary performance indicators and preoxygenation efficiency along with oxygen reserve depletion in patients scheduled for elective surgery under general anesthesia. The main questions it aims to answer are:

What is the relationship between Hand Grip Strength (HGS) and the time taken for end-tidal oxygen (EtO_2) to reach 90% during preoxygenation? What is the relationship between the 6-Minute Walk Test (6MWT) distance and the Oxygen Reserve Index (ORI) depletion time during the apnea period?

Participants will be asked to perform the following tasks during their preoperative and intraoperative care:

Complete a 6-Minute Walk Test (6MWT) to determine preoperative functional capacity.

Perform a Hand Grip Strength (HGS) test using a calibrated hand dynamometer to measure muscle strength.

Undergo standardized preoxygenation with 100% oxygen via a tight-fitting face mask in the operating room while end-tidal oxygen (EtO_2) and Oxygen Reserve Index (ORI) levels are continuously monitored.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged >18 years ASA physical status I-III Scheduled for elective surgery under general anesthesia Voluntary written informed consent to participate in the study

排除标准

  • Severe COPD (Chronic Obstructive Pulmonary Disease) or restrictive lung disease NYHA Class III-IV Heart Failure Neuromuscular diseases Upper extremity pathologies affecting hand function (preventing HGS measurement) Orthopedic or neurological conditions preventing the 6-minute walk test (6MWT) Emergency surgeries

结局指标

主要结局

Preoxygenation Efficiency (EtO_2 Time)

时间窗: From the initiation of preoxygenation (0 seconds) until the EtO_2 values reach 90% (typically within 3 to 5 minutes before anesthesia induction)

The time taken for end-tidal oxygen (EtO\_2) to reach 90% during preoxygenation.

Oxygen Reserve Depletion Time (ORI Time)

时间窗: From the cessation of preoxygenation/initiation of apnea until the ORI drops below 0.55

The time duration for the Oxygen Reserve Index (ORI) value to drop below 0.55.

次要结局

  • Preoperative Functional Capacity (6MWT)(Preoperative period)
  • Preoperative Muscle Strength (HGS)(Preoperative period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Betül Güven

Assos prof

Ankara City Hospital Bilkent

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