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临床试验/NCT06987630
NCT06987630已完成不适用

Effect of Continuous Integrated Pulmonary Index Monitoring on the Incidence of Hypoxemia in Elderly Patients With Painless Colonoscopy

The First People's Hospital of Lianyungang1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2025年6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
已完成
发起方
入组人数
153
试验地点
1
主要终点
Incidence of hypotension

研究概览

简要总结

The purpose of this clinical trial is to integrated pulmonary index to see if there is an effect on the incidence of hypoxemia during painless colonoscopy in older patients.

Does composite pulmonary index monitoring reduce the incidence of hypoxemia? Is there a relationship between the value of the integrated pulmonary index and the patient's pulse oximetry? Continuous monitoring of the integrated pulmonary index in the experimental group was compared with the control group (no detection of the composite lung index) to see if continuous monitoring of the composite pulmonary index could reduce the incidence of hypoxemia in elderly patients.

Participants will:

Oxygen is provided through the nasal cannula, and respiratory parameters (end-tidal carbon dioxide partial pressure (PetCO2), pulse rate [PR], oxygen saturation (SpO2), and respiratory rate (RR) are obtained. The monitor calculates a integrated pulmonary index value (1-10) through mathematical operations.Different measures are taken according to different composite lung indexes, such as when the IPI is ≤6, the patient's jaw is immediately lifted, the oxygen flow rate increases to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated.

Record their vital signs.

详细描述

This study is a single-center, double-blind, prospective, randomized controlled trial. In this experiment, all patients who met the inclusion criteria and did not meet any of the exclusion criteria were divided into SpO2 group (group C) and IPI group (group P) according to 1:1 by computer random number method. After entering the examination room, the two groups of patients signed the informed consent form and underwent vital sign monitoring. Anesthesia process: propofol 1~ 2mg/kg, Intraoperatively, vasoactive drugs such as norepinephrine or ephedrine are used as needed. Group C: SpO2 of the patient's right index finger was monitored with a fingertip oximeter. When the SpO2 decreases by 5% compared with the basic SpO2, the patient's jaw is immediately propped up, and the oxygen flow rate increases to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated. Group P: Fingertip oximetry was used to monitor the SpO2 of the patient's right index finger, and the patient's PETCO2 was monitored with nasal cannula bypass, and when the IPI was ≤6, The patient's jaw is immediately lifted, the oxygen flow rate is increased to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated. Vital signs (blood pressure, heart rate, pulse oximetry or IPI), medication (propofol or vasoactive), anesthesia time and adverse events were recorded in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Patients who were selected for non-intubated painless colonoscopy;
  • •Age≥ 65 years;
  • •American Society of Anesthesiologists (ASA) grade I~III;
  • •Conscious, no cognitive dysfunction and other mental illnesses;
  • •Voluntarily participate in this study and sign the informed consent form

排除标准

  • •Patients with severe circulatory system diseases, respiratory diseases, and central nervous system diseases;
  • •Patients with severe abnormal liver and kidney function;
  • •Those who are allergic to any of the drugs used in the study;
  • •Participated in other clinical studies within the last 3 months

研究组 & 干预措施

P group

Experimental

Nasal cannula oxygen inhalation, oxygen flow rate 3-4L/min, monitor the integrated pulmonary index and SpO2.

干预措施: monitor integrated pulmonary index(IPI) and take appropriate measures (Device)

C group

No Intervention

Nasal cannula oxygen inhalation, oxygen flow rate 3-4L/min,monitor the SpO2,

结局指标

主要结局

Incidence of hypotension

时间窗: Perioperative

the number of patients experiencing low blood pressure

次要结局

  • Adverse reactions (dizziness, nausea, vomiting, etc.)(Perioperative)
  • Adverse reactions (dizziness, nausea, vomiting, etc.)(Perioperative)

研究者

发起方
The First People's Hospital of Lianyungang
申办方类型
Other
责任方
Sponsor

研究点 (1)

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