Evaluation of Consumption of Sevoflurane in Chronic Obstr... | NCT06108973

Studies
Evaluation of Consumption of Sevoflurane in Chronic Obstructive Pulmonary Disease Patients

NCT06108973

Sponsor

Employee's State Insurance Corporation, New Delhi

Status

Unknown status

Last Update Posted

Oct 31, 2023Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Capnography

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Mar 30, 2025Estimated

First Submitted Date

Oct 26, 2023

First Submission Date that Met QC Criteria

Oct 26, 2023

First Posted Date

Oct 31, 2023Actual

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

Oct 26, 2023

Last Update Posted Date

Oct 31, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Santhosh Kumar T N, Nursing Orderly, Employee's State Insurance Corporation, New DelhiPrincipal Investigator

Lead Sponsor

Employee's State Insurance Corporation, New DelhiOTHER_GOV

Collaborators

Name	Class
Medtronic Spine LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

All the Patients undergoing General Anesthesia and the patients who are having Chronic Obstructive Pulmonary Disease will be considered for this study. The Volume consumption of Sevoflurane will be studied in accordance with age, sex, duration , type of surgery, site of surgery and BMI.The volume consumption of sevoflurane is compared with Chronic Obstructive Pulmonary Disease and Normal Patients .

Detailed Description

Chronic Obstructive pulmonary disease is known to escalate the consumption of Inhalation Agents in General Anesthesia. Hence the Data to Collect the Official Record

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Patients		Normal patients without any Lung Pathology for General Anesthesia	Device: Capnography
COPD patients		Established Chronic Obstructive Pulmonary Disease for General Anesthesia	Device: Capnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capnography	Device	To know the Co2 graph in COPD and Normal patients under General Anesthesia	COPD patients Normal Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimation of Volume consumption of Sevoflurane	The consumption is expressed in Volume ml/kg	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both Sex All Age Group Patient willing to give consent COPD patient

Exclusion Criteria:

Not willing to give consent Cancerous Lung Lung Lobectomy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Geography South East Asia-Sothern Peninsular INDIA'

Soci Economic Mid Earning

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Santhosh Kumar T N, BSc	Contact	6366470104		tumakuru572102@gmail.com

Overall Officials

Name	Affiliation	Role
Dr Manjunath, MD	ESIC	Principal Investigator

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

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019296	Capnography

Ancestor Terms

ID	Term
D012129	Respiratory Function Tests
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided