Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries (Lung US)

General anaesthesia results in developement of atelectasis in dependent areas of the lungs exposing patients to an increased risk of hypoxaemia.During pelvic robotic surgeries pneumoperitoneum and steep trendelenburg position further increases atelectasis. Lung Ultrasound imaging is a promising , noninvasive , non-radiant, portable tool to study intraoperative lung atelectasis.

Study Overview

• Status: Completed
• Conditions: Atelectasis
• Intervention / Treatment: Diagnostic test: Lung Ultrasonography (Baseline); Diagnostic test: Lung Ultrasonography ( At the end of surgery)

Detailed Description

Methodology -In the Operation Room 5 lead Electrocardiogram (ECG) , Pulse Oximetry (SPO2 ) , Noninvasive blood pressure (NIBP), End tidal carbon di Oxide (ETCO2 )and core temperature will be monitored , intravenous assess will be established with large bore cannula ,under Local anesthesia Radial artery cannulation will be performed , standard general anesthesia with oral cuffed Endotracheal tube and Intermittent Positive Pressure Ventilation (IPPV ) will be provided to all patients.Anaesthesia will be induced with Fentanyl 1-2 mcg/kg-1 , Morphine 0.5mg/kg-1 ,Propofol sleeping dose , Atracurium 0.5mg/kg-1,and maintained with Air/O2 Sevoflurane , Propofol infusion @100- 150 mcg/kg-1 to maintain Bispectral Index (BIS) between 40 -60 and atracurium infusion to maintain Train -of - Four (TOF Ratio) < 0.5 Baseline Lung Ultrasound Imaging will be performed to record 4 point Lung aeration score ( 0= Normal lung /No aeration loss , 1= mild aeration loss, 2=moderate aeration loss ,3=severe aeration loss ) at T1 - 5 minutes after induction of anaesthesia and before docking robotic instruments in 6 basal zones in both lungs ( 3 zones in each lung ) and labelled as Zone I (Right anterior basal ) Zone II ( Right lateral basal) and Zone III (Right posterior basal) . Zone IV ( Left anterior basal) , Zone V (Left lateral basal ) , Zone VI ( Left Posterior basal ).T2 - Lung Ultrasound Imaging will be performed to record aeration score after removal of robotic arms at the end of robotic surgery and before extubation in 6 basal zones in both lungs.Ti Arterial blood gas 5 minutes after induction of anesthesia and before docking robotic instruments.Tii -Arterial blood gas 5 minutes after the end of robotic surgery and de docking robotic instruments.All patients will receive Positive End Expiratory Pressure (PEEP) 5 cms of water (H2O) intraoperatively . Intraabdominal Pressure will be maintained at 15 cms H2O. Any decrease in Oxygen saturation < 96 % and intervention required will be noted. At the end of surgery , neuromuscular blockade will be reversed , trachea extubated and patient shifted to Postanaesthesia Care Unit.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• India
  • Delhi, India, 110085
    • Rajiv Gandhi Cancer Institute And Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing pelvic robotic surgery under general anaesthesia.

Description

Inclusion Criteria:

* Patients undergoing Robotic Pelvic surgeries under general anaesthesia

Exclusion Criteria:

• Lung consolidation
• Lung fibrosis
• Cardiac failure
• Previous thoracic surgery
• BMI > 32

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung Ultrasonography prior to docking Robotic arms; Base line Lung ultrasonography will be performed in three basal zones for Right and Left lung -Post intubation and prior to docking robotic arms .	Diagnostic test: Lung Ultrasonography (Baseline); Lung Ultrasonography will be performed prior to docking Robotic arms in basal three lung zones on both sides.
Lung Ultrasonography after removal of robotic arms; Lung Ultrasonography will be performed to assess degree of atelectasis after removal of robotic arms and before extubation in three basal zones for Right and Left lung .	Diagnostic test: Lung Ultrasonography ( At the end of surgery); Lung Ultrasonography will be performed after removal of Robotic arms and before extubation in basal three lung zones on both sides to assess degree of atelectasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the degree of lung atelectasis and aeration score.	By performing Lung Ultrasonography in six basal zones ( 3 in each lung)	T1 -Baseline postintubation and before docking robotic arms .T2 - At the end of Robotic surgery upto 6 hours and after removal of robotic arms before extubation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the effect of intraoperative Atelectasis on arterial oxygen tension	Arterial Oxygen tension (PaO2) in mmHg	T1 - Baseline postintubation and before docking robotic arms , T2 -upto 6 hours of robotic surgery and after removal of robotic arms ..
To study the effect of intraoperative atelectasis on Alveolar- arterial Oxygen Gradient	Alveolar - arterial Oxygen gradient will be obtained .	T1 - Baseline postintubation and before docking robotic arms , T2 -upto 6 hours of robotic surgery and removal of robotic arms before extubation.
To study the effect of mode of ventilation on intraoperative atelectasis	Volume controlled ventilation and pressure controlled ventilation if peak airway pressure exceed 35	T1 Baseline T2 Upto 6 hours of Robotic surgery

Collaborators and Investigators

• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
• Investigators: Principal Investigator: Anita Kulkarni, M.D., RajivGandhi Cancer Institute and Research centre , Delhi ,India

Publications and helpful links

General Publications

• Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: June 30, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Lung Ultrasonography; Step Trendelenburg position
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: RGCIRC Lung US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No