HFHO vs CPAP During Thoracic Surgery

Not Applicable

Completed

• Conditions: Hypoxaemia During Surgery; Lung Hyperinflation
• Interventions: Device: CPAP; Device: HFHO

• Registration Number: NCT03894072
• Lead Sponsor: Mahidol University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-28
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HFHO-CPAP	HFHO	This group will have HFHO before CPAP
CPAP-HFHO	HFHO	This group will have CPAP and then HFHO
CPAP-HFHO	CPAP	This group will have CPAP and then HFHO
HFHO-CPAP	CPAP	This group will have HFHO before CPAP

Primary Outcome Measures

Name	Time	Method
Number of participants with improved oxygenation.	20 minutes	Improvement of gas exchanges by arterial blood gases

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital; 🇹🇭 Bangkok, Thailand