Hypoxemia During SurgeryPhase 4ENDOALF-TRNCT07439822
Usefulness of High-flow Oxygen Therapy of Patients at Risk of Hypoxemia Undergoing Digestive Endoscopy Under Deep Sedation
A Phase 4 study testing High-flow medical oxygen insufflation and Low-flow medical oxygen insufflation in people with Hypoxemia During Surgery, run by Outcomes'10 at 1 site in Spain.
Trial summary
The study investigates the use of high-flow oxygen therapy devices in patients at higher risk of complications during sedated digestive endoscopies. Sedation controlled by the endoscopist improves patient tolerance and facilitates higher-quality procedures, but it can have side effects such as hypoxemia or respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia During Surgery
- What is being tested?
- High-flow medical oxygen insufflation and Low-flow medical oxygen insufflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2026to Oct 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥ 18 years old
- Sign the Informed Consent
- Obesity (BMI ≥ 30 kg/m²)
- ASA III
- Stable pulmonary disease (no hospitalization in the last 6 months)
- Stable heart failure (no hospitalization in the last 6 months)
- Diagnosed or suspected obstructive sleep apnea with a score ≥ 3 on the STOP-Bang scale (APPENDIX II)
- History of sedation-related complications in a previous ESP.
Who cannot join
- ASA IV patients
- Worsening heart failure at the time of the endoscopy or unstable (hospitalized < 6 months)
- Worsening respiratory disease at the time of the endoscopy or unstable (hospitalized < 6 months)
- Pregnant women
- Use of home oxygen therapy
- Patients with orotracheal intubation
- Tracheostomized patients
- Patients allergic to or unable to use propofol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Usefulness of High-flow Oxygen Therapy to Improve the Safety of Patients at Risk of Hypoxemia Undergoing Digestive Endoscopy Under Deep Sedation: a Randomized Multicenter Comparative Study
The study investigates the use of high-flow oxygen therapy devices in patients at higher risk of complications during sedated digestive endoscopies. Sedation controlled by the endoscopist improves patient tolerance and facilitates higher-quality procedures, but it can have side effects such as hypoxemia or respiratory depression, especially in patients with sleep apnea, obesity, lung diseases, those over 60 years old, or with a history of sedation complications. While preventive measures, such as oxygen administration, are taken, the study aims to compare the effectiveness of new high-flow oxygen therapy devices with conventional nasal cannulas to improve safety during endoscopies.
- Conditions
- Hypoxemia During Surgery
- Being tested
- High-flow medical oxygen insufflation, Low-flow medical oxygen insufflation
- Keywords
- HIGH-FLOW OXYGEN, SEDATION, HYPOXEMIA
- 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 medical oxygen insufflationDrug
High-flow medical oxygen insufflation
Low-flow medical oxygen insufflationDrug
Low-flow medical oxygen insufflation
| Study group | Role | What they receive |
|---|---|---|
| Low-flow medical oxygen insufflation | Active comparator | Low-flow medical oxygen insufflation Receives: Drug: Low-flow medical oxygen insufflation |
| High-flow medical oxygen insufflation | Experimental | High-flow medical oxygen insufflation Receives: Drug: High-flow medical oxygen insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of hypoxemia
The number of hypoxemia episodes per procedure
Measured: Periprocedural
Severity of episode of hypoxemia pO2 value
Severity of episode of hypoxemia (pO2 90- 80%) - (pO2 <80%)
Measured: Periprocedural
Duration of episode of hypoxemia (in seconds)
Duration of episode of hypoxemia (in seconds)
Measured: Periprocedural
Secondary outcomes (11)
Sex (Demographic and explanatory factors)
Sex (Demographic and explanatory factors)
Measured: Periprocedural
Age (Demographic and explanatory factors)
Age (Demographic and explanatory factors)
Measured: Periprocedural
Body mass index (Demographic and explanatory factors)
Body mass index (Demographic and explanatory factors)
Measured: Periprocedural
Demographic and explanatory factors
anesthetic risk classification: ASA physical status classification
Obstructive Sleep Apnea (OSA) or suspected OSA based on the STOP-Bang questionnaire
Chronic respiratory disease
Chronic heart disease
Chronic use of sedative medications
History of prior respiratory complication during an endoscopic sedation procedure (ESP)
Measured: Periprocedural
Medical History Demographic and explanatory factors
Medical History Demographic and explanatory factors
Measured: Periprocedural
Type of Medication and treatment used (Demographic and explanatory factors)
Type of Medication and treatment used (Demographic and explanatory factors)
Measured: Periprocedural
Demographic and explanatory factors
Duration of diagnostic/ therapeutic endoscopic Procedure
Measured: Periprocedural
Variable results
value of baseline pO2
Measured: Periprocedural
Variable results
Complications and Clinical Events
Measured: Periprocedural
Length of stay at recovery room and post-procedure (Variable results)
Length of stay at recovery room and post-procedure
Measured: Periprocedural
pO2 value (Variable results)
lowest pO2 value during the procedure
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Outcomes'10
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439822
- Sponsor's protocol ID
- ICSCYL-2025-097-OXY
- Acronym
- ENDOALF-TR
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The data will be pseudonymized to ensure privacy and will only be accessible to the research team directly involved in the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of High-flow Oxygen Therapy to Improve the Safety of Patients at Risk of Hypoxemia Undergoing Digestive Endoscopy Under Deep Sedation: a Randomized Multicenter Comparative Study
- ClinicalTrials.gov ID
- NCT07439822
- Acronym / sponsor ID
- ENDOALF-TR / ICSCYL-2025-097-OXY
- Conditions
- Hypoxemia During Surgery
- Keywords
- HIGH-FLOW OXYGEN, SEDATION, HYPOXEMIA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Outcomes'10Research network
- Study start
- Mar 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 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.
The study investigates the use of high-flow oxygen therapy devices in patients at higher risk of complications during sedated digestive endoscopies. Sedation controlled by the endoscopist improves patient tolerance and facilitates higher-quality procedures, but it can have side effects such as hypoxemia or respiratory depression, especially in patients with sleep apnea, obesity, lung diseases, those over 60 years old, or with a history of sedation complications. While preventive measures, such as oxygen administration, are taken, the study aims to compare the effectiveness of new high-flow oxygen therapy devices with conventional nasal cannulas to improve safety during endoscopies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-flow medical oxygen insufflation | Active comparator | Drug: Low-flow medical oxygen insufflationLow-flow medical oxygen insufflation |
| High-flow medical oxygen insufflation | Experimental | Drug: High-flow medical oxygen insufflationHigh-flow medical oxygen insufflation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be ≥ 18 years old
- Sign the Informed Consent
- Obesity (BMI ≥ 30 kg/m²)
- ASA III
- Stable pulmonary disease (no hospitalization in the last 6 months)
Key exclusion criteria (8 listed)
- ASA IV patients
- Worsening heart failure at the time of the endoscopy or unstable (hospitalized < 6 months)
- Worsening respiratory disease at the time of the endoscopy or unstable (hospitalized < 6 months)
- Pregnant women
- Use of home oxygen therapy
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 medical oxygen insufflationHigh-flow medical oxygen insufflation | Drug | High-flow medical oxygen insufflation |
| Low-flow medical oxygen insufflationLow-flow medical oxygen insufflation | Drug | Low-flow medical oxygen insufflation |
Primary outcome
Number of episodes of hypoxemia
Time frame: Periprocedural
The number of hypoxemia episodes per procedure
Severity of episode of hypoxemia pO2 value
Time frame: Periprocedural
Severity of episode of hypoxemia (pO2 90- 80%) - (pO2 <80%)
Duration of episode of hypoxemia (in seconds)
Time frame: Periprocedural
Duration of episode of hypoxemia (in seconds)
11 secondary outcomes
Sex (Demographic and explanatory factors)
Time frame: Periprocedural
Age (Demographic and explanatory factors)
Time frame: Periprocedural
Body mass index (Demographic and explanatory factors)
Time frame: Periprocedural
Demographic and explanatory factors
Time frame: Periprocedural
Medical History Demographic and explanatory factors
Time frame: Periprocedural
Type of Medication and treatment used (Demographic and explanatory factors)
Time frame: Periprocedural
Demographic and explanatory factors
Time frame: Periprocedural
Variable results
Time frame: Periprocedural
Variable results
Time frame: Periprocedural
Length of stay at recovery room and post-procedure (Variable results)
Time frame: Periprocedural
pO2 value (Variable results)
Time frame: Periprocedural
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 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The data will be pseudonymized to ensure privacy and will only be accessible to the research team directly involved in the study.
Related trials for Hypoxemia During Surgery
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Not yet recruiting
Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
Hypoxemia During Surgery
Not yet recruiting
Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
Elderly Patients, Laparoscopic Surgery
Recruiting
High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery
Hypoxemia During Surgery
Enrolling by invitationObservational study
Spontaneous Breathing Mode: A Risk for Hypoxemia During OLV?
Lung Cancer, OLV
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-flow medical oxygen insufflation and Low-flow medical oxygen insufflation in people with Hypoxemia During Surgery, run by Outcomes'10 at 1 site in Spain.
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 8 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 27 Feb 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 episodes of hypoxemia (time frame: Periprocedural). The study lists 3 primary outcomes in all. 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 27 Feb 2026.