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Heated Circuit for One-lung Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649386
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hyun-Chang Kim, Keimyung University Dongsan Medical Center

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.

Condition or disease Intervention/treatment Phase
One-lung Ventilation Oxygenation Temperature Device: Heated and humidified breathing circuit on Device: Heated and humidified breathing circuit off Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Heated-humidified Circuit on Arterial Oxygenation in Patients Undergoing One-lung Ventilation for Thoracoscopic Surgery
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Active Comparator: Control
Heated breathing circuit will turned off.
Device: Heated and humidified breathing circuit off
Heated and humidified breathing circuit will be turned off.

Experimental: Heat
Heated breathing circuit will be turned on.
Device: Heated and humidified breathing circuit on
Heated and humidified breathing circuit will be turned on.




Primary Outcome Measures :
  1. Arterial oxygenation [ Time Frame: At 30 minutes after one-lung ventilation ]
    Arterial oxygenation (mmHg) will be measured by arterial blood analysis.


Secondary Outcome Measures :
  1. Arterial oxygenation [ Time Frame: At 0, 15, 45, and 60 minutes after one-lung ventilation ]
    Arterial oxygenation (mmHg) will be measured by arterial blood analysis.

  2. Mean arterial pressure [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Mean arterial pressure (mmHg) will be measured.

  3. Heart rate [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Heart rate (beats/min) will be measured.

  4. Temperature [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Body temperature (°C) will be measured.

  5. Central venous pressure [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Mean central venous pressure (mmHg) will be measured by a central venous catheter.

  6. Cardiac index [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Cardiac index (l/min/m^2) will be measured by pulse-contour analysis.

  7. Pressure peak [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Peak pressure of ventilation (cmH2O) will be measured.

  8. Pressure plateau [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Plateau pressure of ventilation (cmH2O) will be measured.

  9. Arterial carbon dioxide [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Arterial carbon dioxide will be measured.

  10. Arterial blood acidosis [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Arterial blood acidosis will be measured.

  11. Oxygen saturation of arterial blood [ Time Frame: At 0, 15, 30, 45, and 60 minutes after one-lung ventilation ]
    Oxygen saturation of arterial blood (%) will be measured.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649386


Contacts
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Contact: Hyun-Chang Kim, MD Ph +821028862876 onidori1979@gmail.com

Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
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Principal Investigator: Hyun-Chang Kim, MD PhD Keimyung University

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Responsible Party: Hyun-Chang Kim, Assistant professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT03649386    
Other Study ID Numbers: HeatOLV
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No