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

NCT ID: NCT03296449

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-22
• Study Completion Date: 2018-06-30

Brief Summary

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.

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.

Conditions

One-Lung Ventilation; Thoracic Surgery, Video-Assisted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: PROCEDURE

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).

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).

Group Type: EXPERIMENTAL

HFJV

Intervention Type: PROCEDURE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnant
• Emergent surgery
• Hemodynamic instability

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario de Alicante

OTHER

Sponsor Role: lead

Responsible Party

María Galiana Ivars

Head of the Section of Clinical Anesthesia and Resuscitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Galiana

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario de Alicante

Locations

Hospital General Universitario de Alicante

Alicante, , Spain

Countries

Spain

Other Identifiers

FREQUENCY

Identifier Type: -

Identifier Source: org_study_id