Comparison Between CPAP and HFJV During One-lung Ventilation in VATS

Comparison Between Continuous Positive Airway Pressure and High-frequency Jet Ventilation in Nondependent Lung During One-lung Ventilation in Video-assisted Thoracoscopic Surgery

This study compares two ventilatory techniques (continuous positive airway pressure vs high frequency jet ventilation) during one-lung ventilation (OLV) in video-assisted thoracic surgery (VATS). All patients were ventilated with both ventilatory techniques and parameters of gas exchange were determined through arterial blood gas test.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery, Video-Assisted; One-Lung Ventilation
• Intervention / Treatment: Procedure: CPAP; Procedure: HFJV

Detailed Description

One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV, collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The use of continuous positive airway pressure on non-dependent lung has become the most common technique to achieve that aim.

High-frequency jet ventilation on non-dependent lung may be considered as an alternative way of ventilation of the non-dependent lung during one-lung ventilation because it provides a suitable gaseous exchange while facilitating minimizing surgical field motion. However, this ventilation maneuver is rarely use by thoracic anesthesiologists.

Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This surgical technique becomes even more dependent on immobilization of the operation field than open-chest thoracic procedures. There is a lack of evidence in the current literature regarding the use of HFJV in VATS.

The purpose of this study is to evaluate the effects of HFJV as an alternative for the treatment of hypoxemia in VATS.

One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV, collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The use of continuous positive airway pressure on non-dependent lung has become the most common technique to achieve that aim.

High-frequency jet ventilation on non-dependent lung may be considered as an alternative way of ventilation of the non-dependent lung during one-lung ventilation because provide suitable gaseous exchange while facilitate minimizing surgical field motion. However , this ventilation maneuver is rarely use by thoracic anesthesiologists.

Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This surgical technique becomes even more dependent on immobilization of the operation field than open-chest thoracic procedures. There is a lack of evidence in the current literature about the use of HFJV in VATS.

The purpose of this study is to evaluate the effects of HFJV as an alternative for the treatment of hypoxemia in VATS.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject requiring one-lung ventilation
• Subject under video-assisted thoracic surgery

Exclusion Criteria:

• Pregnant
• Emergent surgery
• Hemodynamic instability

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: One-Lung Ventilation; During one-lung ventilation, when the chest is open, the non-dependent lung is collapsed and manipulated by the surgeon. It is the routine procedure during video-assisted thoracic surgery.
Active Comparator: CPAP to non-dependent lung; The patient will be randomly assigned to the study arm "Continuous Positive Airway Pressure (CPAP)". CPAP will be applied for 20 minutes to the non-dependent lung at a pressure of 2-3cmH20 using the disposable Mallinckrodt Bronchocath CPAP system.	Procedure: CPAP; A recruitment maneuver will be applied to the ventilated lung. Immediately continuous positive airway pressure, at a pressure of 2-3cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP).
Experimental: HFJV to non-dependent lung; The patient is randomly assigned to the study arm "High-frequency jet ventilation (HFJV)". HFJV will be applied for 20 minutes to the non-dependent lung with a driving pressure of a 0.6 atm, respiratory rate 100 cycles per minute using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland).	Procedure: HFJV; A recruitment maneuver will be applied to the ventilated lung. Immediately, high-frequency jet ventilation, with a driving pressure of 0.5 atm and a respiratory rate of 100 cycles per minute will applied to the non-ventilated lung for 20 minutes using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland). Monsoone III is a recognised ventilator design for HFJV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2	Ratio of the arterial oxygen partial pressure (PaO2) to the inspired oxygen fraction (FiO2) determination. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaCO2	Arterial carbon dioxide partial pressure determination. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])	1 day
Operative field conditions	Surgeon's subjective opinion about operating conditions during the interventions: impossible surgical access, acceptable operative filed or excellent operative field). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway pressures	Recording during mechanical ventilation of dependent lung airway pressures. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])	1 day
Adverse effects and complication	Any complication or adverse effect arising from ventilation techniques: need of intensive care unit admissions, re-intervention, or thoracotomy, surgical site infection, anastomosis leakage, and pneumonia.	30 days
Hemodynamic parameters	Heart rate and mean arterial blood pressure. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])	1 day

Collaborators and Investigators

• Sponsor: Hospital General Universitario de Alicante
• Investigators: Principal Investigator: Maria Galiana, Hospital General Universitario de Alicante

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): April 29, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 23, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Hypoxia; High-Frequency Jet Ventilation
• Other Study ID Numbers: FREQUENCY

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
• product manufactured in and exported from the U.S.: No