Study of the Use of Humidified Warmed Gas and the Effect... | NCT00792389

Studies
Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies

NCT00792389

Sponsor

Pennine Acute Hospitals NHS Trust

Status

Unknown status

Last Update Posted

Nov 17, 2008Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Gallstone

Interventions

Warm humidified C02
Cool dry C02

Countries

United Kingdom

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

Nov 2008

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 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Nov 14, 2008

First Submission Date that Met QC Criteria

Nov 14, 2008

First Posted Date

Nov 17, 2008Estimated

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

Nov 14, 2008

Last Update Posted Date

Nov 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200 patients. Outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Patients receiving warmed, humidified gas	Other: Warm humidified C02
2	Active Comparator	Patients receiving cool, day gas	Other: Cool dry C02

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Warm humidified C02	Other	Insufflation of warmed humidified gas during laparoscopic cholecystectomy	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total post operative opiate analgesia - morphine equivalent dose.		1 day

Secondary Outcomes

Measure	Description	Time Frame
Subjective post operative pain as defined on numerical pain scales		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective laparoscopic cholecystectomy
18 years of age or over

Exclusion Criteria:

under 18 years of age
prisoners
converted to open operation
secondary invasive procedure during operation
unable to give consent for whatever reason

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephanie L Trevelyan, MBChB	Contact	01616200420	78985	stephanie.trevelyan@pat.nhs.uk

Overall Officials

Name	Affiliation	Role
David Flook, MBChB	Pennine Acute Hospital NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Oldham Hospital		Oldham	Lancashire	OL1 2JH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones
D002769	Cholelithiasis

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis
D005705	Gallbladder Diseases

Browse Leaves

Not provided

Browse Branches

Not provided