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

Not Applicable

Completed

• Conditions: One-Lung Ventilation; Thoracic Surgery, Video-Assisted
• Interventions: Procedure: HFJV; Procedure: CPAP

• Registration Number: NCT03296449
• Lead Sponsor: Hospital General Universitario de Alicante

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.

Study Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-23
• Study First Posted: 2017-09-28
• Study Start: 2017-11-22
• Primary Completion: 2018-04-29
• Study Completion: 2018-06-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Pregnant
• Emergent surgery
• Hemodynamic instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HFJV to non-dependent lung	HFJV	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).
CPAP to non-dependent lung	CPAP	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.

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2	1 day	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 \[either CPAP or HFJV\])

Secondary Outcome Measures

Name	Time	Method
PaCO2	1 day	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 \[either CPAP or HFJV\])
Operative field conditions	1 day	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 \[either CPAP or HFJV\])

Trial Locations

Locations (1)

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain