跳至主要内容
临床试验/CTRI/2024/10/075590
CTRI/2024/10/075590尚未招募不适用

Performance In 6-Min Walk Test In Prediction Of Postoperative Pulmonary Complication In Major Oncosurgeries And Surgical Gastroentero Surgeries- A Prospective Observational Study

DR S SATHISH KUMAR1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
To Assess The Correaltion Between 6 Minute Walk Test & PPC ( Postoperative Pulmonary Complication).

研究概览

简要总结

The Six minute walk test was introduced for pulmonary evaluation mostly after lung resection surgeries. It is easy to perform, inexpensive and does not need special equipment or trained personnel, hence it is recently included in pre- operative evaluation. It gives an assessment of tolerance of daily activities. Oncology patients have several overlapping factors interfering with exercise capacity and multiple risk factors for post operative pulmonary complications. Changes to the respiratory  system  occur immediately under general anaesthesia. Pulmonary evaluation methods in pre operative period for those at risk are mainly spirometry evaluation of lung function tests ( PFT) and the standard method is cardiopulmonary exercise testing  (CPET). The PFT reports often not reliable as it is influenced by interpretation and patient performance,  while CPET is a complex procedure requiring specialized equipment’s and expertise. Hence alternative methods of functional capacity assessment like 6MWT , incremental shuttle walk test and stair climbing test are useful. **METHODOL****OGY:**After  obtaining  informed  written  consent  all  150  patients  underwent  routine pre operative ,Patients were instructed to walk at their comfortable pace back and forth in the marked track with turn around at either end for a duration of 6 minutes and were informed that they will be allowed to take rest or stop the test incase of discomfort . The test was conducted in a flat , straight hallway 25 metre long where emergency assistance was available along with defibrillator and emergency cart. A stopwatch,  measuring tape, portable pulse oximeter probe ,sphygmomanometer and lap counter Digi Smart Watch were used. The test was stopped if patient experienced any chest pain ,intolerable dyspnea, leg cramps, diaphoresis, pale appearance and medical assistance was given. Before and after the test , the patient’s BP, HR,SPO2 and Borg dyspnea scores were noted. Further the patient’s underwent surgery as planned under general anaesthesia plus epidural anaesthesia and received the routine postoperative care and multi modal analgesia, using epidural analgesia. The occurence of pulmonary complications during post operative period was noted down until discharge from hospital. The PPC included the following: Prolonged mechanical ventilation >48 hours, Atelectasis, Bronchitis, Bronchospasm, ARDS, Pneumonia, Exacerbation of chronic lung disease , respiratory failure.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • History of cardiovascular or pulmonary diseases.
  • Serum albumin≤30g/L.
  • Chronic smoker and chest X Ray with abnormal lung parenchymal / Chest wall findings.
  • ASA PS-II Or III.

排除标准

  • Unstable angina /myocardial infarction/ -Acute coronary syndrome in the previous 6 months -dyspnoea at rest -inability to walk (orthopaedic problems, Cerebrovascular accidents, balance disorders) -unable to interpret or follow instructions, -resting tachycardia(HR ≥120 beats per min/uncontrolled hypertension(BP≥180/100mmofHg).
  • severe pain.

结局指标

主要结局

To Assess The Correaltion Between 6 Minute Walk Test & PPC ( Postoperative Pulmonary Complication).

时间窗: To Assess The Correaltion Between 6 Minute Walk Test & PPC ( Postoperative Pulmonary Complication) in postoperative 72 hours

次要结局

  • To Evaluate(The Incidence Of Complications During 6 Minutes Walk test)
  • To Evaluate Haemodynamics Stability During The Test
  • To Evaluate
  • To evaluate The Impact Of Compounding Factors Like Surgery, Smoking, Respiratory Diseases.
  • To Evaluate(Length Of Hospital Stay)

研究者

发起方
DR S SATHISH KUMAR
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr S SATHISH KUMAR

INSTITUTE OF ANAESTHESIOLOGY,MADURAI MEDICAL COLLEGE

研究点 (1)

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