NCT01725464

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

9 months

First QC Date

November 8, 2012

Last Update Submit

August 16, 2013

Conditions

Lung SurgeryHypoxiaPostoperative

Keywords

thoracotomyoxygen saturationpostoperative

Outcome Measures

Primary Outcomes (1)

  • Mean oxygen saturation at 30 minutes postoperative

    30 minutes

Secondary Outcomes (1)

  • incidence of oxygen saturation < 95% between 120 minutes until 3 days postoperative

    3 days

Study Arms (1)

oxygen cannular

EXPERIMENTAL

Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative

Device: oxygen cannular

Interventions

oxygen cannularDEVICE

Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative

oxygen cannular

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- cannot communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sirilak Suksompong

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sirilak Suksompong, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 12, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

TH(1)