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Clinical Trials/CTRI/2023/07/055279
CTRI/2023/07/055279Not yet recruitingPhase 2

To study the efficacy of ultrasound guided lung recruitment maneuvers on atelectasis in patients undergoing laproscopic cholecystectomy : a randomized control trial

Indira Gandhi Medical College Shimla1 site in 1 country120 target enrollmentStarted: July 25, 2023Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
To compare the LUS scores (LUS Score)in patients receiving ultrasound guided lung recruitment maneuvre for atelectasis, in laproscopic cholecystectomies done under general anaesthesia vs control group ie, in patients not receiving lung recruitment manuvere.

Study Overview

Brief Summary

Recently the application of ultrasound in the diagnosis of lung condition has proven to be safe, noninvasive, easy to use, inexpensive and point of care imaging tool with reproducible results.It can be used to diagnose and monitor atelectasis accurately with asensitivity of 80%.The use of protective lung ventilation has been associated with a lower incidence of atelectasis and pulmonary complications.Although PEEP alone can improve intraoperative oxygenation, studies have shown that use of lung recruitment maneuvres(LRM) and PEEP can improve oxygenation and reduce the incidence of pulmonary complications in patients undergoing laproscopic surgeries.Also the LRMs are useful in reopening the atelectatic lung zones.Prevention of lung atelectasis early in intraoperative period has been reported to lessen the incidence of post operative pulmonary complications.However the studies have included wide and varying types of patient population and diverse surgical procedures, the result of which cannot be applied universally.Therefore it is proposed to selectively evaluate occurence of lung atelectasis in patients undergoing laproscopic cholecystectomy under general annaesthesia and to evaluate the efficacy of lung recruitment manuevers in preventing atelectasis in these patients.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients with healthy lungs (negative imaging findings on chest radiograph or CT), aged between 20 and 40 years old, with a body mass index (BMI)<35 kg / m2, American Society of Anesthesiologists (ASA) physical status I-II undergoing elective laparoscopic cholecystectomy surgery under general anaesthesia.

Exclusion Criteria

  • •Patients with cardiac and neuromuscular diseases.
  • •Those undergoing conversion from laparoscopic to open surgery.
  • •Those experiencing critical postoperative complications such as severe subcutaneous emphysema.

Outcomes

Primary Outcomes

To compare the LUS scores (LUS Score)in patients receiving ultrasound guided lung recruitment maneuvre for atelectasis, in laproscopic cholecystectomies done under general anaesthesia vs control group ie, in patients not receiving lung recruitment manuvere.

Time Frame: 5 time intervals in perioperative period of 24 hours.

Secondary Outcomes

  • To compare the correlation between atelectasis & oxygen saturation & post-operative pulmonary complications(any episode of saturation less than 90% on room air in next 24 hrs)in both the groups.(24 hours)

Investigators

Sponsor
Indira Gandhi Medical College Shimla
Sponsor Class
Government medical college

Study Sites (1)

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