The Effects of Different Degrees of Head-of-bed Elevation on the Respiratory Pattern and Drainage Following Thyroidectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- Respiration rate
研究概览
简要总结
The patient's position is important for ensuring patient comfort and preventing complications after thyroidectomy. This study was carried out to determine the effects of different degrees of head-of-bed elevation on the respiratory pattern and drainage following thyroidectomy and to provide suggestions for evidence-based clinical practice.
详细描述
Thyroidectomy is a safe surgical procedure commonly used for the treatment of benign or malignant tumors, multinodular goiter and Graves disease. However, because of the rich vascular structure of the thyroid gland, serious complications including hemorrhage, hematoma and hematoma-related dyspnea can develop after thyroidectomy. The American Thyroid Association also suggested to keep the patient in a head-up at 45°-Fowler's position in the post anesthesia care unit following thyroidectomy to prevent hematoma formation on the incision site by facilitating venous return from the head and neck. The mentioned guideline does not offer any recommendations regarding the position that should be given to the patients at surgical clinic after thyroidectomy. Therefore, this study aimed to identify the effects of different degrees of head-of-bed elevation on respiratory pattern including respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of drainage and hematoma formation.
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
- Single (Participant)
盲法说明
Group allocation was concealed using individual sealed opaque envelopes that were numbered in sequential order. As individuals were enrolled in the study, the next envelope in the sequence was extracted and the participant was assigned to the groups accordingly. All the researchers except for the clinical nurse who positioned the patients according to randomization list and patients were blinded from group assignment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The eligible participants were those
- •who were not using anticoagulants,
- •whose coagulation tests were normal,
- •who had hemovac drains inserted during thyroidectomy,
- •who had no contraindication to positioning (e.g., heart failure, chronic obstructive pulmonary disease, dyspnea before surgery and respiratory complications in the post-anesthesia care unit),
- •who could tolerate positioning, and who volunteered to participate and signed the informed consent form
排除标准
- •The participants excluded from the study;
- •who were using anticoagulants,
- •whose coagulation tests were abnormal,
- •who had hemovac drains inserted during thyroidectomy,
- •hemovac drains removed in the post-anesthesia care unit following thyroidectomy,
- •who did not tolerate positioning and who refused to participate
研究组 & 干预措施
supine 0 degree head-of-bed elevation
0 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.
干预措施: Head-of-bed elevation (Other)
30 degree head-of-bed elevation
30 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.
干预措施: Head-of-bed elevation (Other)
45 degree head-of-bed elevation
45 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.
干预措施: Head-of-bed elevation (Other)
结局指标
主要结局
Respiration rate
时间窗: Every hour during four hours
Number of breaths per minute. It is counted for one minute.
Peripheral oxygen saturation
时间窗: Every hour during four hours
This oxygen saturation level is used to estimate arterial blood saturation and refers to the amount of oxygenated haemoglobin in the blood. It is measured by an indirect device using non-invasive method.
Amount of drainage
时间窗: Every hour during four hours
Drainage is the accumulation of blood in the drain suction bottle. The symptoms including red drainage and drainage more than 150 ml per hour in the suction bottle are defined as bleeding.The drain in the suction bottle is recorded hourly.
次要结局
- Dyspnea(Every hour during four hours)
- Hematoma formation(Every hour during four hours)
研究者
Serpil Yüksel
Assistant Professor
Necmettin Erbakan University