HFHO vs CPAP During Thoracic Surgery

Effect of High Flow Humidified Oxygen on Non-ventilated Lung During Thoracic Surgery: a Cross-over Study Compared With Conventional CPAP (Continuous Positive Airway Pressure)

A single institutional cross-over study design to compare between high flow humidified oxygen (HFHO) device versus conventional CPAP for non-ventilated lung during thoracic surgery.

Study Overview

• Status: Completed
• Conditions: Hypoxaemia During Surgery; Lung Hyperinflation
• Intervention / Treatment: Device: CPAP; Device: HFHO

Detailed Description

The investigators hypothesize that HFHO may be an alternative tool to supply oxygen to non-ventilated lung during one lung ventilation. CPAP can improve oxygenation at a cost of lung hyperinflation which is an unwanted condition during thoracic surgery especially the video-assisted one.

Recruiting adult patients who undergo lung surgeries that requires one-lung ventilation. Exclusion criteria include the followings:-

1. Emergency case.
2. Patients with severe COPD(Chronic Obstructive Pulmonary Diseases).
3. Patients with moderate baseline hypoxemia (SpO2 < 90% on room air).
4. Patients with severe hemoptysis.
5. Patients with upper or lower airway abnormalities.
6. Patients undergo pulmonary lavage.
7. Patients with known pulmonary hypertension.
8. Patients with known pulmonary/tracheobronchial infections.
9. Patients with suspected difficult airway.
10. Patients with BMI over 35.
11. Pregnant patients.

Following a standard anesthetic practice. All participants will receive an intravenous based anesthetic with or without regional blocks. The appropriate sized double lumen endobronchial tube will be placed and fiberoptic bronchoscope is used to verify a proper position. Patient will also get an arterial line for frequent ABG (Arterial Blood Gases) samplings.

Computer generated randomization will divide patients into 2 groups. Baseline ABG will be drawn. After one lung ventilation commenced for 20 minutes, the 2nd ABG will be drawn, the surgeon who was blinded to the intervention will evaluate the quality of lung collapse using 5-point Likert scale. Then, patients will either receive a CPAP or HFHO (depends on randomization) for 20 minutes. Up on 1st intervention completion, the 3rd ABG and lung collapse evaluation will be performed.

Following the first intervention, the non-ventilated lung will be suctioned out and wait for 20 minutes. Another ABG will be sampled at this point.

The patient will receive the 2nd alternative intervention (CPAP or HFHO- depend on their randomization) for 20 minutes. The final ABG and lung collapse evaluation will be performed.

If any severe hypoxemia/ hypercarbia and marked violation of protocol occurs. Patients will be excluded.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adult > 18 years of age undergoes lung surgeries that required one-lung ventilation

Exclusion Criteria:

• emergency case
• severe COPD
• moderate baseline hypoxemia
• pulmonary hypertension
• difficult upper/lower airway
• BMI > 35
• severe pneumonia
• bronchial lavage
• massive hemoptysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: HFHO-CPAP; This group will have HFHO before CPAP	Device: CPAP; Conventional CPAP; Other Names: Mallinkrodt CPAP; Device: HFHO; A device that can provide heated humidified oxygen up to 30-60 liter per minute, FiO2 (fraction of inspired oxygen) 0.21-0.95; Other Names: Optiflow, Airvo
ACTIVE_COMPARATOR: CPAP-HFHO; This group will have CPAP and then HFHO	Device: CPAP; Conventional CPAP; Other Names: Mallinkrodt CPAP; Device: HFHO; A device that can provide heated humidified oxygen up to 30-60 liter per minute, FiO2 (fraction of inspired oxygen) 0.21-0.95; Other Names: Optiflow, Airvo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with improved oxygenation.	Improvement of gas exchanges by arterial blood gases	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of lung collapsed.	Lung collapse quality by surgeon using 5-point Likert scale where 5 = very good, 4= good, 3 = acceptable, 2 = poor and 1= very poor	20 minutes

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (ACTUAL): March 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: High flow oxygen device, HFHO, CPAP, One-lung ventilation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: Si066/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No