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临床试验/CTRI/2025/06/089867
CTRI/2025/06/089867尚未招募1 期

Targeted Prehabilitation based on PEFR thresholds for optimizing post operative pulmonary outcomes in patients undergoing upper abdominal surgeries.

Dr Meghana P1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
Primary Objective is to evaluate the effectiveness of PEFR guided Prehabilitation in reducing the

研究概览

简要总结

Targeted Prehabilitation focusing on respiratory optimization has shown promise in reducing post operative complications.Peak expiratory flow rate (PEFR) is a simple and reliable measure of airway obstruction and Pulmonary function, and it can be used to serve as an essential tool for tailoring Prehabilitation programmes. Prehabilitation is a multidisciplinary healthcare intervention including exercise, nutritional optimization, and psychological preparation, to dampen the metabolic response to surgery, better withstand a stressful event, shorten the period of recovery, reduce complications, and improve the quality of recovery and quality of life.  During upper abdominal surgeries, intraoperative changes in pulmonary function occur due to decreased lung compliance. In our study, 42 patients of ASA I, II, III aged between 18 and 75 years scheduled for elective surgeries under general anaesthesia will be selected based on inclusion or exclusion criteria. They will be categorized into Mildly reduced PEFR and Severely reduced

PEFR. Patients will receive targeted PEFR guided Prehabilitation. During Preoperative checkup PEFR will be done using Peak flow meter. PEFR will be measured with a portable device, the Mini Portable Peak Flow Meter ranging from 60 to 800 l/min, according to the Guidelines for Pulmonary Function Tests, 2002, with the patient sitting. Patients will be instructed to exert a maximal inspiration to total lung capacity followed by a maximal, short and explosive forced expiration through the measuring device, without extending the measure to residual volume. The expiratory effort needed last only a second or two. Test will be repeated the test three times, considering the best result if the readings did not differ more than 20 ml/ min from each other.  After performing, patients will be classified into 2 categories, i.e, mildly reduced PEFR (60-80%) and severely reduced PEFR (less than 60%). Mildly reduced PEFR group will receive following interventions without supervision at home or in hospital during their stay: Psychological preparation, Dietitian suggested meals with good sugar control, Smoking cessation, Deep breathing exercises that include Incentive spirometry, Aerobic exercises, Coughing and huffing exercises. Severely reduced PEFR group will receive above mentioned interventions as well as extra interventions like the following: Assisted Physiotherapy and Bronchodilator therapy. Both groups will be counseled and prepared psychologically as to why Pre Operative preparation is important. Dietician opinion will be provided regarding the diet they have to follow Preoperatively. Patients who smoke cigarettes or beedis will be advised to stop smoking. They will be made to part in a training program 3 sessions for 3 days before surgery designed to improve the strength and endurance of the inspiratory muscles. A daily diary will be given to each participant to follow up on both exercise training and nutrition requirements so as to evaluate the effectiveness of Prehabilitation in reducing the incidence of post operative pulmonary

complications and improvement in PEFR from preoperative visit to the day after surgery, duration the course of hospital stay and ICU admission (if any).

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • a) ASA I, II, III patients of either sex.
  • b) Patients aged between 18 to 75 years.
  • c) Patients undergoing elective upper abdominal and thoracic surgeries under general anesthesia resulting in a minimum hospital stay of at least 2 days, excluding day case surgery d) Patients willing to participate in this study.

排除标准

  • a) Patients not willing to participate in this study.
  • b) Patients with ASA grade IV c) Patients undergoing emergency surgeries d) Inability to perform PEFR e) Baseline PEFR <30% of predicted values.
  • g) Body mass index in >30kg/m2.

结局指标

主要结局

Primary Objective is to evaluate the effectiveness of PEFR guided Prehabilitation in reducing the

时间窗: Pre operative day 3, 2, 1 and Post operative day 1

incidence of post operative pulmonary complications (pneumonia, post

时间窗: Pre operative day 3, 2, 1 and Post operative day 1

operative ventilation, atelectasis, desaturation, requirement of O2 therapy

时间窗: Pre operative day 3, 2, 1 and Post operative day 1

post operatively).

时间窗: Pre operative day 3, 2, 1 and Post operative day 1

and Improving functional recovery in patients undergoing elective upper

时间窗: Pre operative day 3, 2, 1 and Post operative day 1

abdominal surgeries.

时间窗: Pre operative day 3, 2, 1 and Post operative day 1

次要结局

  • Improvement in PEFR from preoperative visit to the day after surgery and Duration of hospital stay and any ICU admission.(Post operative day 1)

研究者

发起方
Dr Meghana P
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Meghana P

Rajarajeshwari Medical College and Hospital

研究点 (1)

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