NCT04006665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

May 2, 2019

Last Update Submit

April 19, 2023

Conditions

Keywords

Lung UltrasonographyStep Trendelenburg position

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 ..

  • 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.

  • To study the effect of mode of ventilation on intraoperative atelectasis

    T1 Baseline T2 Upto 6 hours of Robotic surgery

Study Arms (2)

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 .

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 .

Diagnostic Test: Lung Ultrasonography ( At the end of surgery)

Interventions

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

Lung Ultrasonography prior to docking Robotic arms

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.

Lung Ultrasonography after removal of robotic arms

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing pelvic robotic surgery under general anaesthesia.

You may qualify if:

  • \* Patients undergoing Robotic Pelvic surgeries under general anaesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, 110085, India

Location

Related 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.

    PMID: 24662376BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Anita Kulkarni, M.D.

    RajivGandhi Cancer Institute and Research centre , Delhi ,India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2019

First Posted

July 5, 2019

Study Start

September 1, 2019

Primary Completion

February 19, 2020

Study Completion

February 28, 2020

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations