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临床试验/NCT06115941
NCT06115941已完成不适用

Using Pre-Operative Incentive Spirometer Reduces Chances of Basal Ateletasis in Patients Undergoing Upper Abdominal Surgeries- A Randomized Control Trial

Dr. Muhammad Naeem1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Decreased frequency in post operative Basal Atelectasis

研究概览

简要总结

ABSTRACT Objective: To compare frequency of basal atelectasis in patients undergoing upper abdominal surgery who are provided pre-operative incentive spirometry versus those not provided pre-operative incentive spirometry

详细描述

After patient selection through "non-probability consecutive sampling" Investigator recorded baseline characteristics of our patients including age, gender and body mass index (BMI). Once recorded, patients will be randomly divided into two equal groups (each containing 37 patients). In group A or "incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file. In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry.

After this, all the included patients underwent upper abdominal surgery by expert surgical team under general anesthesia. Type of surgery (Laparoscopic Cholecystectomy / Open Cholecystectomy / perforated duodenal repair/ Epigastric Hernia Repair / Gastrojejunostomy) and duration for which patient was on ventilator support (in minutes) was documented. After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung".

"The statistical package for social sciences (SPSS) version 22 software was used for statistical analysis of the data. Normality of test will be checked using Shapiro-Wilk test which showed that age and BMI were normally distributed while duration of ventilatory support was non-normal data. For qualitative variables frequency and percentages were used, whereas for quantitative data mean ± standard deviation and median (IQR) were used. Qualitative variables (gender, type of surgery and presence of basal atelectasis) were compared between groups with the use of chi-square test. Quantitative variable (age and BMI) were compared between groups using Student t-test while (duration of ventilatory support) were compared between groups using Mann-Whittney U-test. A p-value of ≤ 0.05 was considered significant".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 53 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age above 18 years
  • •Both gender
  • •ASA I and II
  • •Upper abdominal surgeries

排除标准

  • •Lower abdominal surgeries,
  • •ASA III-V status,
  • •Co-morbidities [like diabetes (HbA1C% ≥ 6.5% 11), hypertension
  • •Chronic lung condition (like asthma, chronic obstructive pulmonary disease, emphysema)
  • •Pulmonary tuberculosis
  • •Structural deformity of chest.

研究组 & 干预措施

Incentive spirometer group

Experimental

incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file.

干预措施: Pre-Op Incentive Spirometer (Device)

No Incentive spirometer group

No Intervention

In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry.

结局指标

主要结局

Decreased frequency in post operative Basal Atelectasis

时间窗: 48 hours after surgery

After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung

次要结局

未报告次要终点

研究者

发起方
Dr. Muhammad Naeem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Muhammad Naeem

Head of the Department of Surgery

Pak Emirates Military Hospital

研究点 (1)

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