Discrepancies in peripheral oxygen saturation estimation by pulse-oximeter in brown-skinned individuals: the OXICOLOUR study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Proportion of patients with Occult hypoxemia
研究概览
简要总结
**Aim:**To identify and quantify the impact of skin colour on oxygen saturation (SpO2) levels measured by pulse-oximeter.
Objectives:
Primary objective:
1. To identify the incidence of “occult hypoxemia†(defined under outcome measures sub-section) in individuals of different skin colour grades.
2. Secondary objectives:
3. To quantify the bias (defined under outcome measures sub-section) in arterial saturation measurement due to skin colour and develop a corrective factor for each skin tone.
4. To compare post-operative outcomes of patients with and without occult hypoxaemia.
To compare serum lactate levels between patients with and without occult hypoxaemia.
Study design: This is a prospective observational study. Skin colour of study participants will be quantified using the Fitzpatrick (17) as well as the Monk’s skin tone (MST) scale (18). Test measurement of SpO2 will be done by the Lifebox pulse-oximeter and the pulseoximeter currently in use at the study site. Pulse-oximeter readings will be taken intra-operatively at two time-points at least 2 hours apart. SpO2 measured by an arterial blood gas analysis (ABGA) will be the gold-standard against which the test measurement will be compared. The test measurement will be taken at the time of collection of the arterial blood sample for ABGA. The ABGA will be done as per the discretion of the anaesthesiologist, as per standard intra-operative management protocols. The difference between the test and gold standard SpO2 measurement for different skin tones will be studied and quantified. Proportion of patients with occult hypoxaemia will be identified for each skin grade.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing major elective oncologic surgery (For example, radical gastrectomy, pancreatic resection, hepatectomy, abdominal compartment resection, radical nephrectomy, retroperitoneal lymph node dissection, radical cystectomy, radical prostatectomy, colorectal resection, total abdominal hysterectomy and salpingo-oophorectomy, and cytoreductive surgeries).
- •Patients requiring an arterial line as part of their standard-of-care.
排除标准
- •Patients undergoing emergency surgery.
- •Hemodynamically unstable patients requiring inotrope support.
- •Hemodynamically stable patients with elective low-dose intra-operative inotrope support of up to 0.05mcg/kg/min will still be included.
- •Haemoglobin less than or equal to 8g/dL at the time of surgery.
- •On mechanical ventilation prior to surgery.
- •Pre-existing local skin or nail disorders preventing accurate measurement of SpO2 by pulse-oximeter.
- •Patients with intrathoracic surgical procedures; to avoid potential confounding factors related to lung parenchymal resections, single-lung ventilation or mediastinal dissection.
结局指标
主要结局
Proportion of patients with Occult hypoxemia
时间窗: Pulse oximetry readings will be obtained at the time of intra-operative and immediate post-operative sampling for ABGA
次要结局
- 1. Bias in measurement of arterial saturation(2. In-hospital mortality defined as death due to any cause from date of inclusion to date of discharge from the hospital.)
研究者
Dr Reshma Ambulkar
Tata Memorial Centre