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临床试验/NCT06997666
NCT06997666已完成不适用

The Effect of Prone Position on Oxygen Saturation, Blood Gas Parameters, and Respiratory Rate in Intensive Care Patients With COVID-19-induced ARDS

Medet Korkmaz1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年3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
90
试验地点
1
主要终点
Change in Oxygen Saturation (SpO₂)

研究概览

简要总结

This randomized controlled trial aimed to investigate the effect of the prone position on oxygen saturation, arterial blood gas parameters, and respiratory rate in intensive care patients diagnosed with COVID-19-induced Acute Respiratory Distress Syndrome (ARDS). A total of 90 patients (45 in the prone positioning group and 45 in the control group) were included. The intervention group received a 30-minute prone positioning procedure, while the control group received standard ICU care. Data were collected using a Demographic Information Form and clinical monitoring of respiratory and blood gas parameters across six time points over two days.

详细描述

This randomized controlled trial investigated the short-term physiological effects of prone positioning in intubated intensive care patients diagnosed with COVID-19-induced Acute Respiratory Distress Syndrome (ARDS). A total of 90 patients were included, with 45 in the experimental group and 45 in the control group. Patients in the experimental group were placed in the prone position for 30 minutes on two consecutive days, while the control group received standard ICU care without prone positioning.

Oxygen saturation (SpO₂, SaO₂), arterial blood gas parameters (PO₂, PCO₂, pH, lactate, sodium), and respiratory rate were measured at six time points to evaluate the effectiveness of the intervention. The study was conducted in the general and intermediate intensive care units of a public hospital in eastern Turkey, which was designated as a COVID-19 treatment center during the pandemic.

The study's primary objective was to determine whether prone positioning could improve oxygenation and respiratory efficiency in critically ill patients with COVID-19-related ARDS. Secondary outcomes included changes in blood gas and metabolic parameters. The results suggested that prone positioning had a beneficial impact on oxygen saturation and respiratory rate without causing adverse changes in blood gas chemistry. The study was ethically approved and conducted in accordance with the Declaration of Helsinki.

研究设计

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

入排标准

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

入选标准

  • •Age 40 years or older
  • •Admission to an intensive care unit (ICU)
  • •Confirmed diagnosis of COVID-19
  • •Developed Acute Respiratory Distress Syndrome (ARDS) due to COVID-19
  • •Intubated at the time of enrollment
  • •Provided informed verbal and written consent (or consent provided by legal representative)

排除标准

  • •Significant hearing or vision impairments affecting communication
  • •Cognitive impairment or inability to understand instructions
  • •Patient died during the course of the study
  • •Early discharge from intensive care before completion of all measurements
  • •Non-intubated patients whose level of consciousness could not be monitored

研究组 & 干预措施

Prone Position Group

Experimental

Patients in this group were placed in the prone position for 30 minutes once daily on two consecutive days. Oxygen saturation (SpO₂), blood gas parameters (SaO₂, PO₂, PCO₂, pH, lactate, sodium), and respiratory rate were measured before and after the intervention. No other treatment was altered.

干预措施: Prone Position (Procedure)

Supine Standard Care Group

No Intervention

Patients in this group received standard intensive care in the supine position. No additional interventions were applied. Oxygen saturation (SpO₂), blood gas parameters (SaO₂, PO₂, PCO₂, pH, lactate, sodium), and respiratory rate were measured at the same intervals as the intervention group.

结局指标

主要结局

Change in Oxygen Saturation (SpO₂)

时间窗: Baseline and six repeated measurements over two consecutive days

Measurement of arterial oxygen saturation (SaO₂), partial pressure of oxygen (PO₂), partial pressure of carbon dioxide (PCO₂), and pH from blood gas analysis to assess respiratory and metabolic effects of prone positioning.

次要结局

  • Change in Arterial Blood Gas Parameters (SaO₂, PO₂, PCO₂, pH)(Baseline and six repeated measurements over two consecutive days)

研究者

发起方
Medet Korkmaz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Medet Korkmaz

professor

Inonu University

研究点 (1)

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