Morbid ObesityNCT04048798
Nasal High Flow in Bariatric Surgery
A study testing Oxygen therapy via HFNC and Oxygen therapy via face mask in people with Morbid Obesity, run by Istanbul University.
Trial summary
High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. Group I patients will be applied HFNC before and after bariatric surgery, Group II patients will be applied a constant O2 concentration via face mask. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Oxygen therapy via HFNC and Oxygen therapy via face mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Feb 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a body mass index of 40-55 kg/m2
- American Society of Anesthesiologists score II-III
- Patients undergoing laparoscopic sleeve gastrectomy or one anastomosis gastric bypass
Who cannot join
- Obstructive sleep apnea syndrome
- Using a non invasive mechanical ventilation device preoperatively
- Patients whoo will predicted to postanesthesia care unit admission postoperatively
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Nasal High Flow on Perioperative Oxygenation in Patients Undergoing Bariatric Surgery
High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. Group I patients will be applied HFNC before and after bariatric surgery, Group II patients will be applied a constant O2 concentration via face mask. Oxygen pressure, oxygen saturation, carbon dioxide, respiration frequency, forced vital capacity will be measured before and after surgery.
Read the detailed description
Morbid obese patients are prone to atelectasis and hypoxemia after bariatric surgery. High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. It provides 5-7 cm H2O positive end expiratory pressure to the airways and may prevent atelectasis. In the preoperative room, forced vital capacity, peripheral oxygen saturation (SpO2), respiratory frequency, heart rate (HR), blood pressure (BP), carbon dioxide, oxygen pressure and carbon dioxide partial pressure values in blood gas analysis will be recorded. We will apply HFNC in the preoperative and postoperative period to Group I patients, while applying a constant O2 concentration to Group II patients. After appliying HFNC for two hours in Group I patients and O2 via face mask in Group II patients measurements will be repeated. During surgery, similar mechanical ventilation parameters will be applied to the patients. After the operation Group I patients will be applied HFNC, while Group II patients will be applied O2 via face mask in the recovery room for two hours. Measurements will be repeated. Primary end point of the study is the association between oxygen pressure, carbon dioxide partial pressure values among preoperative before and after HFNC and O2 and postoperative times.
- Conditions
- Morbid Obesity
- Being tested
- Oxygen therapy via HFNC, Oxygen therapy via face mask
- Keywords
- morbid obesity, bariatric surgery, high frequency nasal cannula, oxygenation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapy via HFNCOther
Oxygen treatment will be applied to the patients via HFNC before and after surgery
Oxygen therapy via face maskOther
Oxygen treatment will be applied to the patients via face mask before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| Oxygen therapy via HFNC | Active comparator | Patients who will be applied high frequency nasal cannula before and after surgery Receives: Other: Oxygen therapy via HFNC |
| Oxygen therapy via face mask | Active comparator | Patients who will be applied O2 via face mask before and after surgery Receives: Other: Oxygen therapy via face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
PO2 value
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
Measured: 24 hours
PCO2 value
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Cigdem Akyol Beyoğlu, Istanbul University
- Investigators
- Cigdem A BEYOGLU, Principal investigator, İstanbul Üniversitesi- Cerrahpaşa Cerrahpaşa Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048798
- Sponsor's protocol ID
- 88298
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I am unaware of the advantages or disadvantages of sharing IPD
Publications
Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. doi: 10.1111/j.1365-2044.2007.05104.x.
PubMed 17635423
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasal High Flow on Perioperative Oxygenation in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04048798
- Acronym / sponsor ID
- 88298
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, bariatric surgery, high frequency nasal cannula, oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 7 Aug 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.
High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. Group I patients will be applied HFNC before and after bariatric surgery, Group II patients will be applied a constant O2 concentration via face mask. Oxygen pressure, oxygen saturation, carbon dioxide, respiration frequency, forced vital capacity will be measured before and after surgery.
Detailed description
Morbid obese patients are prone to atelectasis and hypoxemia after bariatric surgery. High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. It provides 5-7 cm H2O positive end expiratory pressure to the airways and may prevent atelectasis. In the preoperative room, forced vital capacity, peripheral oxygen saturation (SpO2), respiratory frequency, heart rate (HR), blood pressure (BP), carbon dioxide, oxygen pressure and carbon dioxide partial pressure values in blood gas analysis will be recorded. We will apply HFNC in the preoperative and postoperative period to Group I patients, while applying a constant O2 concentration to Group II patients. After appliying HFNC for two hours in Group I patients and O2 via face mask in Group II patients measurements will be repeated. During surgery, similar mechanical ventilation parameters will be applied to the patients. After the operation Group I patients will be applied HFNC, while Group II patients will be applied O2 via face mask in the recovery room for two hours. Measurements will be repeated. Primary end point of the study is the association between oxygen pressure, carbon dioxide partial pressure values among preoperative before and after HFNC and O2 and postoperative times.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen therapy via HFNC | Active comparator | Other: Oxygen therapy via HFNCPatients who will be applied high frequency nasal cannula before and after surgery |
| Oxygen therapy via face mask | Active comparator | Other: Oxygen therapy via face maskPatients who will be applied O2 via face mask before and after surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a body mass index of 40-55 kg/m2
- American Society of Anesthesiologists score II-III
- Patients undergoing laparoscopic sleeve gastrectomy or one anastomosis gastric bypass
Key exclusion criteria (3 listed)
- Obstructive sleep apnea syndrome
- Using a non invasive mechanical ventilation device preoperatively
- Patients whoo will predicted to postanesthesia care unit admission postoperatively
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 |
|---|---|---|
| Oxygen therapy via HFNCOxygen treatment will be applied to the patients via HFNC before and after surgery | Other | Oxygen therapy via HFNC |
| Oxygen therapy via face maskOxygen treatment will be applied to the patients via face mask before and after surgery | Other | Oxygen therapy via face mask |
Primary outcome
PO2 value
Time frame: 24 hours
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
PCO2 value
Time frame: 24 hours
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 17635423Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. doi: 10.1111/j.1365-2044.2007.05104.x.
- Individual participant dataSharing planned: No. I am unaware of the advantages or disadvantages of sharing IPD
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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.
Cigdem A BEYOGLU principal investigator
İstanbul Üniversitesi- Cerrahpaşa Cerrahpaşa Tıp Fakültesi
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen therapy via HFNC and Oxygen therapy via face mask in people with Morbid Obesity, run by Istanbul University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cigdem A BEYOGLU (+905052278176, akyolbeyoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PO2 value (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048798, which also lists 1 linked publication.
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 7 Aug 2019; AzTrials last refreshed its copy on 2 Nov 2026.