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临床试验/CTRI/2025/03/081571
CTRI/2025/03/081571尚未招募不适用

Evaluation of Lung Ultrasound as a screening tool to detect Early Post Operative Complications following major upper open abdominal surgeries

Dr Hemant kumar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月2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
100
试验地点
1
主要终点
Incidence of PPC’s with lung ultrasound and Chest X-ray in

研究概览

简要总结

Post operative pulmonary complications (PPC) are respiratory

complications that occur within 48–72 hours following surgery. PPCs can

adversely influence recovery course of the patient in post operative period.

Incidence of PPCs is 5– 10% in patients undergoing non-thoracic surgery and

22% in high-risk patients (1).Even with minor surgeries, the incidence has been

reported up to 1–2%.

There is a wide spectrum of PPCs like pleural effusion, pneumothorax,

atelectasis, consolidation, pulmonary collapse, ARDS and interstitial syndrome

(2- 4) which can occur after non-thoracic or major abdominal surgeries, which

may affect clinical outcomes of the patient. The distinctive characteristic of

PPC’s is that they are preventable or modifiable to a certain extent even in

postoperative period. Many studies have been done to assess the preoperative

risk factors associated with PPC’s (5). Early detection of PPCs would enable

physicians to startintervention in time and, therefore prevent its negative impact

on patient outcome; hence, there is increasing interest in early detection of

pulmonarycomplications in post operative period to reduce patient’s morbidity

and mortality (1, 5).

Chest auscultations and chest radiograph are commonly used as diagnostic

modalities to detect PPCs in wards and ICU but have finite diagnostic accuracy

(6-9). Computed tomography (CT) is the gold standard for pulmonary pathology

but it is associated with significant ionizing radiation and the need for transfers

within the hospital, which has risks of its own (6). Interpretation with better

precision of chest infiltrates can be obtained by CT but due to its risk of

irradiation, less availability, cost factor and need of patient’s transportation to

radiology department; it is preferable only PPCs are strongly indicated.

1

Summary

Bedside Point of Care Lung Ultrasound (POCUS) is prompt, easy, non-

expensive and radiation free technique. It has been found that it has excellent

diagnostic accuracy for PPCs like pleural effusion, consolidation, pneumothorax,

atelectasis etc. in critically ill patients as compared to CT thorax. (6,7,9) CT

scanning requires transportation of a potentially critically ill patient which poses

huge risk to the patients. Also, CT scanning is associated with significant costs,

radiation and contrast burden. Lung ultrasonography is the answer to these

limitations.

Routine early lung ultrasound may detect PPCs early and with higher

accuracy to improve management in postoperative period, hence reducing patient

morbidity and over all adding to provision of better health care in major upper

gastrointestinal surgery especially open ones, which have higher chance of

PPC’s as compared to laparoscopic surgeries. (7, 10, 11)

Recent studies have revealed the role of ultrasound in detecting PPCs in

cardiac surgery and thoracic surgery and they have reported that ultrasound of the

lung can be helpful in detecting PPCs at early stage as compared to chest Xray

and can be used as a primary imaging technique to detect PPCs in post operative

period.

Patients undergoing major open abdominal surgeries have higher risk of

developing PPC’s due to many causes like surgical incision near diaphragm,

long duration of surgery, prolong immobility and inability to clear secretions.

This is the rationale behind our study to select this group i.e., patients

undergoing major abdominal surgery. Moreover, there are very few studies in

the literature which investigated the role of POCUS in detection of PPC’s (12)

Despite the less use of diagnostic X-rays in wards, the study has been designed

to compare the use of lung ultrasound and chest X-ray every 24 hrs for next 72

hrs. So the purpose of this prospective, observational study is to evaluate the

role of bedside ultrasound as a screening tool to assess patients’ lungs in post

operative period following major upper abdominal surgeries to detect PPCs at an

early stage and to compare it with chest x-ray.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient refusal to give consent Patient ASA physical status 3, 4, and Emergency cases Patients with any preoperative respiratory involvement either coexisting or diagnosed during the preoperative assessment (clinically/ radiologically or sonologicaly).

排除标准

  • Patient refusal to give consent Patient ASA physical status 3, 4, and Emergency cases Patients with any preoperative respiratory involvement either coexisting or diagnosed during the preoperative assessment (clinically/ radiologically or sonologicaly).

结局指标

主要结局

Incidence of PPC’s with lung ultrasound and Chest X-ray in

时间窗: Baseline, post op.. Day 1,Day2,Day3

early post operative period.

时间窗: Baseline, post op.. Day 1,Day2,Day3

次要结局

  • 1.Requirement of O2 supplementation(And Mode of O2 therapy)

研究者

发起方
Dr Hemant kumar
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mamta Harzai

DR RMLIMS LUCKNOW

研究点 (1)

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