CTRI/2024/11/076704尚未招募不适用
Effect of pulmonary prehabilitation on post-operative pulmonary complications in patients undergoing surgery for oral cancer: A randomized control study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To determine the incidence of post-operative pulmonary complications in patients undergoing surgery for oral cancer with or without pulmonary prehabilitation.
研究概览
简要总结
Post-operative pulmonary complications(PPC) are defined as any complications affecting the respiratory system after anaesthesia and surgery. Their incidence after major surgery varies widely, from <1% to 23%. PPC are more common than cardiac complications and account for significantly increased length of stay and cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 90 years 2) Patients consenting for the study 3) Biopsy proven oral cancer, undergoing surgery as the primary modality of treatment with curative intent.
- •Duration of surgery more than 3 hours.
排除标准
- •Exclusion Criteria:
- •Patients with preexisting cardiopulmonary comorbidities.
- •Patients with functional dependence for daily activities.
- •Surgery causing oral incompetence which makes incentive spirometry difficult.
- •Patients with tracheostomy or requiring tracheostomy during surgery.
- •Patients undergoing salvage surgery for recurrence.
- •Patients undergoing emergency surgery for re-exploration or second surgery.
- •Patients unable to follow instructions in IMT or the patient information sheet.
- •Patients in whom IMT is contraindicated a) History of spontaneous pneumothorax b) Traumatic pneumothorax that has not fully healed c) Burst eardrum or other conditions of the eardrum d) Unstable asthma with an abnormally low perception of dyspnoea.
结局指标
主要结局
To determine the incidence of post-operative pulmonary complications in patients undergoing surgery for oral cancer with or without pulmonary prehabilitation.
时间窗: From the time of hospital admission till discharge.
次要结局
- To determine the utility of the existing scoring system ARISCAT as a predictor of post- operative pulmonary complications following surgery for oral cancer.(ARISCAT scoring will be calculated at 8 weeks of recruitment into study.)
研究者
Shruthi Patil V
Christian medical college
研究点 (1)
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