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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04006665
Other study ID # RGCIRC Lung US
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date February 28, 2020

Study information

Verified date April 2023
Source Rajiv Gandhi Cancer Institute & Research Center, India
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 28, 2020
Est. primary completion date February 19, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: * Patients undergoing Robotic Pelvic surgeries under general anaesthesia Exclusion Criteria: - Lung consolidation - Lung fibrosis - Cardiac failure - Previous thoracic surgery - BMI > 32

Study Design


Related Conditions & MeSH terms


Intervention

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 ( 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.

Locations

Country Name City State
India Rajiv Gandhi Cancer Institute and Research Centre Delhi

Sponsors (1)

Lead Sponsor Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 ..
Secondary 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.
Secondary 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
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