NCT03649386

Brief Summary

One-lung ventilation interrupts oxygenation. The effect of heated humidifed breathing circuit on arterial oxygenation during one-lung ventilation has not been investigated. The investigators will investigate the effect of the heated humidifed breathing circuit on oxygenation during one-lung ventilation in patients undergoing thoracoscopic surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Status
unknown

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

First Submitted

Initial submission to the registry

August 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 22, 2018

Last Update Submit

August 27, 2018

Conditions

One-lung VentilationOxygenationTemperature

Outcome Measures

Primary Outcomes (1)

  • Arterial oxygenation

    Arterial oxygenation (mmHg) will be measured by arterial blood analysis.

    At 30 minutes after one-lung ventilation

Secondary Outcomes (11)

  • Arterial oxygenation

    At 0, 15, 45, and 60 minutes after one-lung ventilation

  • Mean arterial pressure

    At 0, 15, 30, 45, and 60 minutes after one-lung ventilation

  • Heart rate

    At 0, 15, 30, 45, and 60 minutes after one-lung ventilation

  • Temperature

    At 0, 15, 30, 45, and 60 minutes after one-lung ventilation

  • Central venous pressure

    At 0, 15, 30, 45, and 60 minutes after one-lung ventilation

  • +6 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Heated breathing circuit will turned off.

Device: Heated and humidified breathing circuit off

Heat

EXPERIMENTAL

Heated breathing circuit will be turned on.

Device: Heated and humidified breathing circuit on

Interventions

Heated and humidified breathing circuit onDEVICE

Heated and humidified breathing circuit will be turned on.

Heat
Heated and humidified breathing circuit offDEVICE

Heated and humidified breathing circuit will be turned off.

Control

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist class I-II
  • Patients scheduled for one-lung ventilation for thoracoscopic surgery

You may not qualify if:

  • Obesity
  • Severe obstructive or restrictive lung disease
  • Preoperative oxygen supply
  • Preoperative intubated state or under mechanical ventilatory support
  • Baseline arterial partial pressure of oxygen (PaO2) \< 70 mmHg
  • Symptomatic coronary or peripheral arterial disease
  • Renal failure
  • Preoperative continuous infusion of inotropes or vasopressor
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hyun-Chang Kim, MD PhD

    Keimyung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Chang Kim, MD Ph

CONTACT

+821028862876onidori1979@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 28, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

August 28, 2018

Record last verified: 2018-08