Hypoxemia During SurgeryHIFI-NIVATSNCT07432607
High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery
A study testing High-Flow Nasal Oxygen Therapy (HFNOT) and Conventional Oxygen Mask (COM) in people with Hypoxemia During Surgery, run by Ebru Girgin Dinc at 1 site in Turkey (Türkiye).
Trial summary
This is a prospective, randomized, parallel-group clinical trial designed to evaluate the effects of high-flow nasal oxygen therapy (HFNOT) versus conventional oxygen mask (COM) on perioperative hypoxia in patients undergoing video-assisted thoracoscopic (VATS) pericardial window procedures under sedoanalgesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypoxemia During Surgery
- What is being tested?
- High-Flow Nasal Oxygen Therapy (HFNOT) and Conventional Oxygen Mask (COM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- Scheduled for elective video-assisted thoracoscopic pericardial window procedure under sedoanalgesia
- ASA Physical Status Classification I-III
- Able and willing to provide written informed consent
Who cannot join
- Age <18 or >75 years
- ASA Physical Status ≥ IV
- Body Mass Index (BMI) > 30 kg/m²
- Need for inotropic support at enrollment
- Preoperative hemodynamic instability
- Symptomatic respiratory disease (e.g., pneumonia, nasal congestion, asthma attack)
Show all 14Show fewer
- Diagnosed neuromuscular disorder
- Diagnosed tracheal stenosis
- Local infection at the site of regional block application
- Coagulopathy or bleeding diathesis
- Pregnancy
- Patients refusing sedoanalgesia
- Patients refusing study participation
- Conversion to general anesthesia or use of supraglottic airway intraoperatively
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kosuyolu Heart Training and Research Hospital
Istanbul, KARTAL, 34860
Ebru GIRGIN DINC, 905446948852, grgnebru@gmail.com
Esin ERDEM, MD, Anaesthesiologist
About this study
Official title: Optimizing Oxygen Delivery During Sedoanalgesia for Video-Assisted Thoracoscopic Pericardial Window: High-Flow Nasal Oxygen vs. Face Mask Oxygenation, A Prospective Comparative Study
This is a prospective, randomized, parallel-group clinical trial designed to evaluate the effects of high-flow nasal oxygen therapy (HFNOT) versus conventional oxygen mask (COM) on perioperative hypoxia in patients undergoing video-assisted thoracoscopic (VATS) pericardial window procedures under sedoanalgesia. The pericardial window procedure, indicated for diagnostic and therapeutic drainage of pericardial effusion, is traditionally performed under general anesthesia. However, the use of non-intubated VATS with sedoanalgesia has gained popularity due to reduced morbidity, shorter recovery, and avoidance of complications associated with general anesthesia, especially in elderly and comorbid patients.
During non-intubated VATS, the occurrence of hypoxia and hemodynamic instability may be exacerbated by procedural pneumothorax and underlying cardiac pathology. High-flow nasal oxygen therapy may provide physiological benefits in this setting by reducing airway resistance, improving alveolar ventilation, and minimizing dead space.
The primary outcome of the study is to compare the incidence of perioperative hypoxia between HFNOT and COM groups. Secondary outcomes include patient comfort, intraoperative oxygenation profiles, hemodynamic stability, and recovery parameters. The trial will be conducted at a single academic center with eligible patients randomized into two treatment arms.
Read the detailed description
Pericardial effusion may require therapeutic or diagnostic drainage by pericardiocentesis or creation of a surgical "pericardial window." Video-assisted thoracoscopic surgery (VATS) is the preferred minimally invasive approach, but standard practice employs general anesthesia with tracheal intubation. Since the late 1980s, non-intubated VATS (NI-VATS) performed under sedoanalgesia with regional blocks has gained acceptance, offering lower morbidity, shorter recovery, and avoidance of postoperative pulmonary complications-advantages that are especially valuable in elderly or comorbid patients who are at risk of hypotension or cardiac arrest during induction.
During NI-VATS, iatrogenic pneumothorax and underlying cardiac pathology can precipitate perioperative hypoxia. Conventional oxygen delivery (facemask or low-flow nasal cannula at ≤15 L min-¹) may be insufficient. High-flow nasal oxygen therapy (HFNOT) delivers warmed, humidified gas at up to 70 L min-¹ and FiO₂ 0.21-1.00, matching or exceeding peak inspiratory flow, reducing airway resistance, washing out nasopharyngeal dead space, and improving alveolar ventilation. Perioperative data on HFNOT in NI-VATS remain limited.
In this study, the primary objective is to compare the incidence of intraoperative hypoxia (defined as SpO₂ < 92%) in patients receiving high-flow nasal oxygen therapy (HFNOT) versus a conventional oxygen mask (COM) during sedoanalgesia-guided non-intubated video-assisted thoracoscopic (NI-VATS) pericardial window procedures.
Secondary objectives include the comparison of oxygen saturation trends and nadir SpO₂ values; hemodynamic stability (heart rate and mean arterial pressure); arterial blood gas parameters (pO₂, pCO₂, pH, lactate, and base excess); regional cerebral oxygen saturation (NIRS); procedural and recovery times; postoperative pain scores (VAS); the need for intensive care unit admission; length of hospital stay; and the incidence of pulmonary or cardiovascular complications.
- Conditions
- Hypoxemia During Surgery
- Being tested
- High-Flow Nasal Oxygen Therapy (HFNOT), Conventional Oxygen Mask (COM)
- Keywords
- hypoxemia, High Flow Oxygen Therapy, non-ıntubated VATS
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Oxygen Therapy (HFNOT)Device
Heated and humidified oxygen will be administered through a high-flow nasal cannula. Flow rates will up to 70 L/min with an FiO₂ of 0.21 to 1.00, delivered at a temperature of 37°C. The intervention will be applied from entry into the operating room until the end of the surgical procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery.
Conventional Oxygen Mask (COM)Device
Oxygen will be delivered via a standard face mask up to 15 L/min with an FiO₂ of 0.21-1.00. The oxygen support will be provided from entry into the operating room until the end of the procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery.
| Study group | Role | What they receive |
|---|---|---|
| Conventional oxygen mask (COM) | Active comparator | Up to 15 liters/min via oxygen mask Receives: Device: High-Flow Nasal Oxygen Therapy (HFNOT) |
| High-flow nasal oxygen therapy (HFNOT) | Active comparator | Warmed, humidified up to 70 L min-¹, FiO₂ 0.21-1.00 via dedicated nasal cannula Receives: Device: Conventional Oxygen Mask (COM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation Trends
Oxygen Saturation Ratio (%)
Measured: Up to postoperative 30 minutes
Secondary outcomes (8)
Oxygen Saturation Trends
Oxygen saturation ratio (%)
Measured: Up to postoperative 24 hours
Change in Heart Rate Value
İntraoperative Rate of Change in heart rate (%)
Measured: Up to postoperative 30 minutes
Arterial Blood Gas Parameters
Changes in pH during perioperative periods.
Measured: Up to postoperative 24 hours
Regional Cerebral Oxygen Saturation
Intraoperative NIRS values variability (% change)
Measured: Up to postoperative 0 minutes
Need for intensive care
Number of patients requiring intensive care within a total of 24 hours
Measured: Up to postoperative 24 hours
Length of Hospital Stay
Number of days hospitalized after the procedure.
Measured: Up to 7 days
Postoperative Pulmonary and Cardiovascular Complications
Number of complications score (atelectasis, pneumonia, arrhythmia, or hypotension)
Measured: Up to postoperative 3 day
Mean arterial pressure fluctuations
Intraoperative rate of change in mean arterial pressure (%)
Measured: Up to postoperative 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemia 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ebru Girgin Dinc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru Girgin Dinc, Koşuyolu Kartal Heart Training and Research Hospital
- Investigators
- Atakan ERKILINC, MD, Ass. Prof., Study chair, Kosuyolu Kartal Heart Training and Research HospitalEsin ERDEM, MD, Principal investigator, Kosuyolu Kartal Heart Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432607
- Sponsor's protocol ID
- HFNO/25/16/915
- Acronym
- HIFI-NIVATS
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and statistical analysis plan may be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Oxygen Delivery During Sedoanalgesia for Video-Assisted Thoracoscopic Pericardial Window: High-Flow Nasal Oxygen vs. Face Mask Oxygenation, A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07432607
- Acronym / sponsor ID
- HIFI-NIVATS / HFNO/25/16/915
- Conditions
- Hypoxemia During Surgery
- Keywords
- hypoxemia, High Flow Oxygen Therapy, non-ıntubated VATS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ebru Girgin DincUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Feb 2026 (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.
This is a prospective, randomized, parallel-group clinical trial designed to evaluate the effects of high-flow nasal oxygen therapy (HFNOT) versus conventional oxygen mask (COM) on perioperative hypoxia in patients undergoing video-assisted thoracoscopic (VATS) pericardial window procedures under sedoanalgesia. The pericardial window procedure, indicated for diagnostic and therapeutic drainage of pericardial effusion, is traditionally performed under general anesthesia. However, the use of non-intubated VATS with sedoanalgesia has gained popularity due to reduced morbidity, shorter recovery, and avoidance of complications associated with general anesthesia, especially in elderly and comorbid patients.
During non-intubated VATS, the occurrence of hypoxia and hemodynamic instability may be exacerbated by procedural pneumothorax and underlying cardiac pathology. High-flow nasal oxygen therapy may provide physiological benefits in this setting by reducing airway resistance, improving alveolar ventilation, and minimizing dead space.
The primary outcome of the study is to compare the incidence of perioperative hypoxia between HFNOT and COM groups. Secondary outcomes include patient comfort, intraoperative oxygenation profiles, hemodynamic stability, and recovery parameters. The trial will be conducted at a single academic center with eligible patients randomized into two treatment arms.
Detailed description
Pericardial effusion may require therapeutic or diagnostic drainage by pericardiocentesis or creation of a surgical "pericardial window." Video-assisted thoracoscopic surgery (VATS) is the preferred minimally invasive approach, but standard practice employs general anesthesia with tracheal intubation. Since the late 1980s, non-intubated VATS (NI-VATS) performed under sedoanalgesia with regional blocks has gained acceptance, offering lower morbidity, shorter recovery, and avoidance of postoperative pulmonary complications-advantages that are especially valuable in elderly or comorbid patients who are at risk of hypotension or cardiac arrest during induction.
During NI-VATS, iatrogenic pneumothorax and underlying cardiac pathology can precipitate perioperative hypoxia. Conventional oxygen delivery (facemask or low-flow nasal cannula at ≤15 L min-¹) may be insufficient. High-flow nasal oxygen therapy (HFNOT) delivers warmed, humidified gas at up to 70 L min-¹ and FiO₂ 0.21-1.00, matching or exceeding peak inspiratory flow, reducing airway resistance, washing out nasopharyngeal dead space, and improving alveolar ventilation. Perioperative data on HFNOT in NI-VATS remain limited.
In this study, the primary objective is to compare the incidence of intraoperative hypoxia (defined as SpO₂ < 92%) in patients receiving high-flow nasal oxygen therapy (HFNOT) versus a conventional oxygen mask (COM) during sedoanalgesia-guided non-intubated video-assisted thoracoscopic (NI-VATS) pericardial window procedures.
Secondary objectives include the comparison of oxygen saturation trends and nadir SpO₂ values; hemodynamic stability (heart rate and mean arterial pressure); arterial blood gas parameters (pO₂, pCO₂, pH, lactate, and base excess); regional cerebral oxygen saturation (NIRS); procedural and recovery times; postoperative pain scores (VAS); the need for intensive care unit admission; length of hospital stay; and the incidence of pulmonary or cardiovascular complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional oxygen mask (COM) | Active comparator | Device: High-Flow Nasal Oxygen Therapy (HFNOT)Up to 15 liters/min via oxygen mask |
| High-flow nasal oxygen therapy (HFNOT) | Active comparator | Device: Conventional Oxygen Mask (COM)Warmed, humidified up to 70 L min-¹, FiO₂ 0.21-1.00 via dedicated nasal cannula |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 75 years
- Scheduled for elective video-assisted thoracoscopic pericardial window procedure under sedoanalgesia
- ASA Physical Status Classification I-III
- Able and willing to provide written informed consent
Key exclusion criteria (14 listed)
- Age <18 or >75 years
- ASA Physical Status ≥ IV
- Body Mass Index (BMI) > 30 kg/m²
- Need for inotropic support at enrollment
- Preoperative hemodynamic instability
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 |
|---|---|---|
| High-Flow Nasal Oxygen Therapy (HFNOT)Heated and humidified oxygen will be administered through a high-flow nasal cannula. Flow rates will up to 70 L/min with an FiO₂ of 0.21 to 1.00, delivered at a temperature of 37°C. The intervention will be applied from entry into the operating room until the end of the surgical procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery. | Device | Conventional oxygen mask (COM) |
| Conventional Oxygen Mask (COM)Oxygen will be delivered via a standard face mask up to 15 L/min with an FiO₂ of 0.21-1.00. The oxygen support will be provided from entry into the operating room until the end of the procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery. | Device | High-flow nasal oxygen therapy (HFNOT) |
Primary outcome
Oxygen Saturation Trends
Time frame: Up to postoperative 30 minutes
Oxygen Saturation Ratio (%)
8 secondary outcomes
Oxygen Saturation Trends
Time frame: Up to postoperative 24 hours
Change in Heart Rate Value
Time frame: Up to postoperative 30 minutes
Arterial Blood Gas Parameters
Time frame: Up to postoperative 24 hours
Regional Cerebral Oxygen Saturation
Time frame: Up to postoperative 0 minutes
Need for intensive care
Time frame: Up to postoperative 24 hours
Length of Hospital Stay
Time frame: Up to 7 days
Postoperative Pulmonary and Cardiovascular Complications
Time frame: Up to postoperative 3 day
Mean arterial pressure fluctuations
Time frame: Up to postoperative 0 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. The study protocol and statistical analysis plan may be shared upon reasonable request.
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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.
Atakan ERKILINC, MD, Ass. Prof. study chair
Kosuyolu Kartal Heart Training and Research Hospital
Esin ERDEM, MD principal investigator
Kosuyolu Kartal Heart Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Flow Nasal Oxygen Therapy (HFNOT) and Conventional Oxygen Mask (COM) in people with Hypoxemia During Surgery, run by Ebru Girgin Dinc at 1 site in Turkey (Türkiye).
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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru GIRGIN DINC, MD (905446948852, grgnebru@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation Trends (time frame: Up to postoperative 30 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 5 May 2026.