Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries

Atelectasis Clinical Trial

— Lung US  

Official title:

Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006665
• Other study ID #: RGCIRC Lung US
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

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