Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries

Completed

• Conditions: Atelectasis
• Interventions: Diagnostic Test: Lung Ultrasonography (Baseline); Diagnostic Test: Lung Ultrasonography ( At the end of surgery)

• Registration Number: NCT04006665
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

Brief 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.

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 Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-06-30
• Study First Posted: 2019-07-05
• Study Start: 2019-09-01
• Primary Completion: 2020-02-19
• Study Completion: 2020-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung Ultrasonography prior to docking Robotic arms	Lung Ultrasonography (Baseline)	Base line Lung ultrasonography will be performed in three basal zones for Right and Left lung -Post intubation and prior to docking robotic arms .
Lung Ultrasonography after removal of robotic arms	Lung Ultrasonography ( At the end of surgery)	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 .

Primary Outcome Measures

Name	Time	Method
To assess the degree of lung atelectasis and aeration score.	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.	By performing Lung Ultrasonography in six basal zones ( 3 in each lung)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 Delhi, India