Heated Circuit for One-lung Ventilation

Effect of Heated-humidified Circuit on Arterial Oxygenation in Patients Undergoing One-lung Ventilation for Thoracoscopic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Temperature; One-lung Ventilation; Oxygenation
• Intervention / Treatment: Device: Heated and humidified breathing circuit off; Device: Heated and humidified breathing circuit on

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial oxygenation	Arterial oxygenation (mmHg) will be measured by arterial blood analysis.	At 30 minutes after one-lung ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial oxygenation	Arterial oxygenation (mmHg) will be measured by arterial blood analysis.	At 0, 15, 45, and 60 minutes after one-lung ventilation
Mean arterial pressure	Mean arterial pressure (mmHg) will be measured.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Heart rate	Heart rate (beats/min) will be measured.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Temperature	Body temperature (°C) will be measured.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Central venous pressure	Mean central venous pressure (mmHg) will be measured by a central venous catheter.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Cardiac index	Cardiac index (l/min/m^2) will be measured by pulse-contour analysis.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Pressure peak	Peak pressure of ventilation (cmH2O) will be measured.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Pressure plateau	Plateau pressure of ventilation (cmH2O) will be measured.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Arterial carbon dioxide	Arterial carbon dioxide will be measured.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Arterial blood acidosis	Arterial blood acidosis will be measured.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation
Oxygen saturation of arterial blood	Oxygen saturation of arterial blood (%) will be measured.	At 0, 15, 30, 45, and 60 minutes after one-lung ventilation

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Investigators: Principal Investigator: Hyun-Chang Kim, MD PhD, Keimyung University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HeatOLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No