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

One-Lung Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296449
• Other study ID #: FREQUENCY
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2019
• Source: Hospital General Universitario de Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2018
• Est. primary completion date: April 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject requiring one-lung ventilation

• Subject under video-assisted thoracic surgery

Exclusion Criteria:

• Pregnant

• Emergent surgery

• Hemodynamic instability

Related Conditions & MeSH terms

• One-Lung Ventilation
• Thoracic Surgery, Video-Assisted

Intervention

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).
• 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.

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario de Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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