Hypoxaemia During SurgeryNCT03894072
HFHO vs CPAP During Thoracic Surgery
A study testing CPAP and HFHO in people with Hypoxaemia During Surgery and Lung Hyperinflation, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypoxaemia During Surgery, Lung Hyperinflation
- What is being tested?
- CPAP and HFHO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult > 18 years of age undergoes lung surgeries that required one-lung ventilation
Who cannot join
- emergency case
- severe COPD
- moderate baseline hypoxemia
- pulmonary hypertension
- difficult upper/lower airway
- BMI > 35
Show all 9Show fewer
- severe pneumonia
- bronchial lavage
- massive hemoptysis
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Bangkok, 10700
About this study
Official title: 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.
Read the 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:-
- Emergency case.
- Patients with severe COPD(Chronic Obstructive Pulmonary Diseases).
- Patients with moderate baseline hypoxemia (SpO2 < 90% on room air).
- Patients with severe hemoptysis.
- Patients with upper or lower airway abnormalities.
- Patients undergo pulmonary lavage.
- Patients with known pulmonary hypertension.
- Patients with known pulmonary/tracheobronchial infections.
- Patients with suspected difficult airway.
- Patients with BMI over 35.
- 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
- Hypoxaemia During Surgery, Lung Hyperinflation
- Being tested
- CPAP, HFHO
- Keywords
- High flow oxygen device, HFHO, CPAP, One-lung ventilation
- Medical subject headings
- Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Mallinkrodt CPAP
Conventional CPAP
HFHODevice
Also called Optiflow, Airvo
A device that can provide heated humidified oxygen up to 30-60 liter per minute, FiO2 (fraction of inspired oxygen) 0.21-0.95
| Study group | Role | What they receive |
|---|---|---|
| HFHO-CPAP | Active comparator | This group will have HFHO before CPAP Receives: Device: CPAP; Device: HFHO |
| CPAP-HFHO | Active comparator | This group will have CPAP and then HFHO Receives: Device: CPAP; Device: HFHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improved oxygenation.
Improvement of gas exchanges by arterial blood gases
Measured: 20 minutes
Secondary outcomes (1)
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
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Mar 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxaemia During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- HFHO-CPAP CPAP-HFHO
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prasert Sawasdiwipachai, Mahidol University
- Investigators
- Prasert Sawasdiwipachai, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894072
- Sponsor's protocol ID
- Si066/2019
- Status last verified
- May 2021
- First submitted
- 27 Mar 2019
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03894072
- Acronym / sponsor ID
- Si066/2019
- Conditions
- Hypoxaemia During Surgery, Lung Hyperinflation
- Keywords
- High flow oxygen device, HFHO, CPAP, One-lung ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:-
- Emergency case.
- Patients with severe COPD(Chronic Obstructive Pulmonary Diseases).
- Patients with moderate baseline hypoxemia (SpO2 < 90% on room air).
- Patients with severe hemoptysis.
- Patients with upper or lower airway abnormalities.
- Patients undergo pulmonary lavage.
- Patients with known pulmonary hypertension.
- Patients with known pulmonary/tracheobronchial infections.
- Patients with suspected difficult airway.
- Patients with BMI over 35.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- HFHO-CPAP CPAP-HFHO
| Arm | Type | Receives |
|---|---|---|
| HFHO-CPAP | Active comparator | Device: CPAP, Device: HFHOThis group will have HFHO before CPAP |
| CPAP-HFHO | Active comparator | Device: CPAP, Device: HFHOThis group will have CPAP and then HFHO |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult > 18 years of age undergoes lung surgeries that required one-lung ventilation
Key exclusion criteria (9 listed)
- emergency case
- severe COPD
- moderate baseline hypoxemia
- pulmonary hypertension
- difficult upper/lower airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: Mallinkrodt CPAPConventional CPAP | Device | CPAP-HFHO, HFHO-CPAP |
| HFHOAlso: Optiflow, AirvoA device that can provide heated humidified oxygen up to 30-60 liter per minute, FiO2 (fraction of inspired oxygen) 0.21-0.95 | Device | CPAP-HFHO, HFHO-CPAP |
Primary outcome
Number of participants with improved oxygenation.
Time frame: 20 minutes
Improvement of gas exchanges by arterial blood gases
1 secondary outcome
Quality of lung collapsed.
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasert Sawasdiwipachai, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and HFHO in people with Hypoxaemia During Surgery and Lung Hyperinflation, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with improved oxygenation. (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.