AtelectasisLung USNCT04006665
Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries
An observational study of Atelectasis, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- Lung Ultrasonography (Baseline) and Lung Ultrasonography ( At the end of surgery)
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2019to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing pelvic robotic surgery under general anaesthesia.
Who may be able to join
- Patients undergoing Robotic Pelvic surgeries under general anaesthesia
Who cannot join
- Lung consolidation
- Lung fibrosis
- Cardiac failure
- Previous thoracic surgery
- BMI > 32
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atelectasis
- Being tested
- Lung Ultrasonography (Baseline), Lung Ultrasonography ( At the end of surgery)
- Keywords
- Lung Ultrasonography, Step Trendelenburg position
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Diagnostic Test: Lung Ultrasonography (Baseline) | |
| 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 . Receives: Diagnostic Test: Lung Ultrasonography ( At the end of surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the degree of lung atelectasis and aeration score.
By performing Lung Ultrasonography in six basal zones ( 3 in each lung)
Measured: 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 outcomes (3)
To study the effect of intraoperative Atelectasis on arterial oxygen tension
Arterial Oxygen tension (PaO2) in mmHg
Measured: T1 - Baseline postintubation and before docking robotic arms , T2 -upto 6 hours of robotic surgery and after removal of robotic arms ..
To study the effect of intraoperative atelectasis on Alveolar- arterial Oxygen Gradient
Alveolar - arterial Oxygen gradient will be obtained .
Measured: T1 - Baseline postintubation and before docking robotic arms , T2 -upto 6 hours of robotic surgery and removal of robotic arms before extubation.
To study the effect of mode of ventilation on intraoperative atelectasis
Volume controlled ventilation and pressure controlled ventilation if peak airway pressure exceed 35
Measured: T1 Baseline T2 Upto 6 hours of Robotic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Sep 2019
- Primary completion19 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Anita Kulkarni, M.D., Principal investigator, RajivGandhi Cancer Institute and Research centre , Delhi ,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006665
- Sponsor's protocol ID
- RGCIRC Lung US
- Acronym
- Lung US
- Status last verified
- Apr 2023
- First submitted
- 2 May 2019
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24662376
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries
- ClinicalTrials.gov ID
- NCT04006665
- Acronym / sponsor ID
- Lung US / RGCIRC Lung US
- Conditions
- Atelectasis
- Keywords
- Lung Ultrasonography, Step Trendelenburg position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Ultrasonography prior to docking Robotic arms | – | Diagnostic Test: 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 | – | Diagnostic Test: 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 . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing pelvic robotic surgery under general anaesthesia.
Key inclusion criteria (1 listed)
- Patients undergoing Robotic Pelvic surgeries under general anaesthesia
Key exclusion criteria (5 listed)
- Lung consolidation
- Lung fibrosis
- Cardiac failure
- Previous thoracic surgery
- BMI > 32
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Ultrasonography (Baseline)Lung Ultrasonography will be performed prior to docking Robotic arms in basal three lung zones on both sides. | Diagnostic test | Lung Ultrasonography prior to docking Robotic arms |
| 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. | Diagnostic test | Lung Ultrasonography after removal of robotic arms |
Primary outcome
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)
3 secondary outcomes
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 ..
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.
To study the effect of mode of ventilation on intraoperative atelectasis
Time frame: T1 Baseline T2 Upto 6 hours of Robotic surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Background: PubMed 24662376Acosta 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.
- Individual participant dataSharing planned: No
Related trials for Atelectasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Kulkarni, M.D. principal investigator
RajivGandhi Cancer Institute and Research centre , Delhi ,India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atelectasis, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.