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临床试验/NCT05964309
NCT05964309尚未招募不适用

Effect of Preoxygenation in Sitting Position on The Oxygen Reserve Index (ORI) Alarm Time as Early Predictor of Impending Hypoxemia During Prolonged Apnea

Imam Abdulrahman Bin Faisal University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
56
试验地点
1
主要终点
Oxygen reserve index (ORI)alarming time

研究概览

简要总结

This prospective, controlled and randomized study aims at comparing the effect of position on the oxygen reserve index alarm time which is considered as predictor of hypoxemia in prolonged apnea which might be faced during general anesthesia (GA) in several situations such as the time from induction of anesthesia till endotracheal intubation.

participants will be divided into two groups; supine (n=38) and sitting group (n=38) both group will undergo elective procedures under GA and endotracheal intubation

详细描述

Introduction Pre oxygenation with high fraction of inspired oxygen is not only recommended before anesthesia induction and intubation but also to delay apnea induced hypoxemia in a variety of airway management and patients with limited oxygen reserve. As well as, to prolong the duration of apneic oxygenation in some airway interventions. Several methods have been used to improve the efficiency of pre oxygenation with controversial outcome. One of these methods is the performance of pre oxygenation in head up position.

During anesthetic management, pulse oximeter has been considered as valuable noninvasive tool for monitoring of patient oxygen saturation (SpO2%).

However, the relationship between the oxygen saturation (SpO2%) and the arterial partial pressure of oxygen (PaO2) restricts the pulse oximeter monitoring of patient oxygenation due to the sigmoidal pattern of this relation, as small changes only in SpO2% occur with increase in arterial oxygen tension above 80 mmHg., Therefore, when oxygen is provided, SpO2 remains 100% over a wide range of PaO2 (>80 mmHg) So It does not reflect the degree of hyperoxia during oxygen supplementation. On the other hand, when PaO2 is falling, the SpO2 may remain 100% until the PaO2 falls below approximately 80 mm Hg. Thus, it does not predict the onset of hypoxia in an apneic patient.

Oxygen reserve index (ORI) is a non-invasive real time non-unit scale between 0.00 and 1.00, which reflects the level of venous blood oxygen saturation (SvO2). When the patient is breathing room air ORI is 0.00, With oxygen supplementation, after SpO2 reaches its plateau of 100%, SvO2 continues rising as PaO2 increasing, and at PaO2 200mmHg usually ORI reaches a plateau. Hence ORI will serve to indicate PaO2 trends (rising or falling) in the range of 100-200 mmHg), so it will reflect the range of moderate hyperoxia (PaO2 ranging from 100 to 200 mmHg) during oxygen supply and, on the other hand, it will predict impending desaturation ahead of standard pulse oximetry during safe prolonged apnea technique in surgical patients at high risk.

Our study aims at assessment of the effect of pre oxygenation in sitting position on the ORI warning time for impending de-saturation during safe prolonged apnea techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Elective surgery
  • •Age 18-60 years
  • •General Anesthesia with endotracheal intubation

排除标准

  • •Significant cardiac or pulmonary disease.
  • •Anticipated difficult intubation.
  • •History of seizures.
  • •BMI 30kg/m2 or more.

研究组 & 干预措施

Supine group(Control group)

Experimental

Supine group (flat head position- n=28) during pre-oxygenation patients will be in supine position

干预措施: supine group (Other)

sitting group

Experimental

Sitting position (90 degree head up position- n=28) during pre-oxygenation patients will be in 90 degree head up position

干预措施: sitting group (Other)

结局指标

主要结局

Oxygen reserve index (ORI)alarming time

时间窗: baseline, immediately after intubation, ORI warning alarm

time from intubation till ORI alarm in minutes

次要结局

  • Maximum Oxygen Reserve(Baseline, immediately after preoxygenation)
  • safe apnea time(baseline, immediately after intubation, when SpO2 % drop to 94% assessed in first 10 minutes after induction of general anesthesia)

研究者

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

Roshdi R Almetwalli

Professor

Imam Abdulrahman Bin Faisal University

研究点 (1)

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