Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2019-03-01
2019-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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HFHO-CPAP
This group will have HFHO before CPAP
CPAP
Conventional CPAP
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
CPAP-HFHO
This group will have CPAP and then HFHO
CPAP
Conventional CPAP
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
Interventions
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CPAP
Conventional CPAP
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* severe COPD
* moderate baseline hypoxemia
* pulmonary hypertension
* difficult upper/lower airway
* BMI \> 35
* severe pneumonia
* bronchial lavage
* massive hemoptysis
18 Years
99 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Prasert Sawasdiwipachai
Associate professor
Principal Investigators
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Prasert Sawasdiwipachai, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Bangkok, , Thailand
Countries
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Other Identifiers
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Si066/2019
Identifier Type: -
Identifier Source: org_study_id
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