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Completed

NCT Number: NCT04006665

Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, 110085, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing Robotic Pelvic surgeries under general anaesthesia

Exclusion criteria

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

Treatment and study plan

Lung Ultrasonography (Baseline)

Diagnostic Test

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)

Diagnostic Test

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.

Primary outcomes

  1. To assess the degree of lung atelectasis and aeration score.

    Time frame: 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 outcomes

  1. To study the effect of intraoperative Atelectasis on arterial oxygen tension

    Time frame: 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

  2. To study the effect of intraoperative atelectasis on Alveolar- arterial Oxygen Gradient

    Time frame: 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 .

  3. To study the effect of mode of ventilation on intraoperative atelectasis

    Time frame: T1 Baseline T2 Upto 6 hours of Robotic surgery

    Volume controlled ventilation and pressure controlled ventilation if peak airway pressure exceed 35

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Acronym: Lung US

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Apr 21, 2023

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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