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Clinical Trials/CTRI/2023/08/056843
CTRI/2023/08/056843CompletedNot Applicable

Assessment of changes in lung aeration and diaphragmatic function using ultrasonography in laparoscopic abdominal surgery prospective Observational study

ESI Post Graduates Institute of Medical Sciences and Research New Delhi1 site in 1 country40 target enrollmentStarted: January 9, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To measure the changes in modified LUS score

Study Overview

Brief Summary

Aim is to study the changes in lung aeration and diaphragmatic function in elective laparoscopic abdominal surgery.

Total 40 patients will be enrolled for this study according to inclusion and exclusion criteria.

Study is prospective Observational non randomised study

Written informed consent will be taken from the patients.

All patients will be undergoing ultrasonographic scan of bilateral lung zones and score according to Modified Lung Ultrasound Score at following time points

Time point A: pre-operative room

Time point B: after intubation

Time point C: after deflation of pneumoperitoneum

Time point D: 30 minutes after the arrival of patients in the recovery room

Time point E: before discharge from the recovery room at 24 hours

Diaphragmatic function will be assessed using M- mode of USG at time point A, D and E

Primary objectives is to assess the changes in Bilaterally lung aeration score.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA grade I and II Elective laparoscopic cholecystectomy surgery.

Exclusion Criteria

  • BMI more than 35 Obstetric patients History of intra-thoracic procedures.

Outcomes

Primary Outcomes

To measure the changes in modified LUS score

Time Frame: Time point A: pre-operative room | Time point B: after intubation | Time point C: after deflation of pneumoperitoneum | Time point D: 30 minutes after the arrival of patients in the recovery room | Time point E: before discharge from the recovery room at 24 hours

Secondary Outcomes

  • To measure the changes in diaphragmatic excursion(Time point A: pre-operative room)

Investigators

Sponsor
ESI Post Graduates Institute of Medical Sciences and Research New Delhi
Sponsor Class
Research institution and hospital

Study Sites (1)

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