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

NCT03296449 | Completed

• 1 other identifier: FREQUENCY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

One-Lung Ventilation; Thoracic Surgery, Video-Assisted

Keywords

Hypoxia; High-Frequency Jet Ventilation; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PaCO2

  1 day

• Operative field conditions

  1 day

Other Outcomes (3)

• Airway pressures

  1 day

• Adverse effects and complication

  30 days

• Hemodynamic parameters

  1 day

Study Arms (3)

One-Lung Ventilation

NO INTERVENTION

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.

CPAP to non-dependent lung

ACTIVE COMPARATOR

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

HFJV to non-dependent lung

EXPERIMENTAL

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

Interventions

CPAP 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).

CPAP to non-dependent lung

HFJV 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.

HFJV to non-dependent lung

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant
• Emergent surgery
• Hemodynamic instability

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead

Study Sites (1)

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Galiana

  Hospital General Universitario de Alicante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Section of Clinical Anesthesia and Resuscitation

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 28, 2017
• Study Start: November 22, 2017
• Primary Completion: April 29, 2018
• Study Completion: June 30, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

ES (1)