NCT03006224

Brief Summary

Smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. Hypoxemia and airway damage can be associated with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway damage during one lung ventilation for lobectomy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

December 22, 2016

Last Update Submit

April 4, 2017

Conditions

SmokingOxygen Deficiencies

Keywords

secondary smokingone lung ventilationarterial oxygen tensionlobectomy

Outcome Measures

Primary Outcomes (3)

  • arterial oxygen tension

    From beginning of Anesthesia to 1st day of surgery

  • arterial carbon dioxide tension

    From beginning of Anesthesia to 1st day of surgery

  • intraoperative peak airway pressure

    during intraoperative ventilation

Study Arms (2)

Group S (non smoking and secondary smoking)

ACTIVE COMPARATOR

I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.

Other: One Lung Ventilation

Group SS (secondary smoking)

ACTIVE COMPARATOR

I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.

Other: One Lung Ventilation

Interventions

One Lung VentilationOTHER
Group S (non smoking and secondary smoking)Group SS (secondary smoking)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3.

You may not qualify if:

  • Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SmokingHypoxia

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 30, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 4, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04