To Evaluate the Role of Lung Ultrasonography for Detectio... | NCT03144310

Studies
To Evaluate the Role of Lung Ultrasonography for Detection of Atlelectasis in Robot Assisted Laproscopic Pelvic Sugeries

NCT03144310

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Last Update Posted

Jan 3, 2018Actual

Enrollment

32Actual

Phase

Not provided

Conditions

to Detect the Incidence of Atelectasis

Interventions

lung ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2016Actual

Primary Completion Date

Nov 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

May 4, 2017

First Submission Date that Met QC Criteria

May 4, 2017

First Posted Date

May 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2017

Last Update Posted Date

Jan 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Rahul Kathuria, junior resident doctor, Post Graduate Institute of Medical Education and Research, ChandigarhPrincipal Investigator

Lead Sponsor

Post Graduate Institute of Medical Education and Research, ChandigarhOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis inclusion criteria: age 18 to 70 yrs age ASA I and II robot assisted pelvic surgeries in steep trendelenburg position

exclusion criteria: cardiac disese severe obstructive and restrictive disease upper airways infection ASAIII and IV

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lung ultrasound	Other	lung ultrasound and blood gas		blood gas analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of atelectasis	incidence of atelectasis in adults after extubation undergoing robot assisted pelvic laproscopic surgery in steep trendelenberg position using ultrasound	24hrs

Secondary Outcomes

Measure	Description	Time Frame
risk factor identification	risk factor identification of post operative atelectasis	24hrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA Iand II age 18-70 yrs robot assisted pelvis surgeries

Exclusion Criteria:

ASA II and IV cardiac and lung disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

ASA Iand II age 18-70 yrs

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pgimer	Post Graduate Institute of Medical Education and Research, Chandigarh	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001784	Blood Gas Analysis

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided