The Effect of Nasal Cannula During the First 2 Hours Post... | NCT01725464

Studies
The Effect of Nasal Cannula During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy

NCT01725464

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Aug 19, 2013Estimated

Enrollment

34Actual

Phase

Phase 4

Conditions

Lung Surgery
Hypoxia
Postoperative

Interventions

oxygen cannular

Countries

Thailand

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

Aug 2013

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 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Nov 8, 2012

First Submission Date that Met QC Criteria

Nov 9, 2012

First Posted Date

Nov 12, 2012Estimated

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

Aug 16, 2013

Last Update Posted Date

Aug 19, 2013Estimated

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

During early postoperative after lung resection surgery, patients without oxygen supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen mask or cannular. In this study the investigators want to the sudy the effect of oxygen supplementation via oxygen cannular during the first 120 minutes after surgery

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oxygen cannular	Experimental	Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative	Device: oxygen cannular

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxygen cannular	Device	Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative	oxygen cannular

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean oxygen saturation at 30 minutes postoperative		30 minutes

Secondary Outcomes

Measure	Description	Time Frame
incidence of oxygen saturation < 95% between 120 minutes until 3 days postoperative		3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age =/> 18 years
lobectomy or pneumonectomy or wedge resection
ASA 1-3
preoperative oxygen saturation < 95 %
receiving epidural analgesia

Exclusion Criteria:

- cannot communication

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

Not provided

Overall Officials

Name	Affiliation	Role
Sirilak Suksompong, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sirilak Suksompong		Bangkok		10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided