Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries

NCT ID: NCT04006665

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-02-28

Brief Summary

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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

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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.

Conditions

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Atelectasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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 .

Lung Ultrasonography (Baseline)

Intervention Type DIAGNOSTIC_TEST

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 .

Lung Ultrasonography ( At the end of surgery)

Intervention Type 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.

Interventions

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Lung Ultrasonography (Baseline)

Lung Ultrasonography will be performed prior to docking Robotic arms in basal three lung zones on both sides.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\* Patients undergoing Robotic Pelvic surgeries under general anaesthesia

Exclusion Criteria

* Lung consolidation
* Lung fibrosis
* Cardiac failure
* Previous thoracic surgery
* BMI \> 32
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

Sponsor Role lead

Responsible Party

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Dr Anita Kulkarni

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anita Kulkarni, M.D.

Role: PRINCIPAL_INVESTIGATOR

RajivGandhi Cancer Institute and Research centre , Delhi ,India

Locations

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Rajiv Gandhi Cancer Institute and Research Centre

Delhi, , India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 24662376 (View on PubMed)

Other Identifiers

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RGCIRC Lung US

Identifier Type: -

Identifier Source: org_study_id

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