HypoxemiaNCT07445256
Recovery Hypoxemia After Sedated Upper Gastrointestinal Endoscopy
An observational study of Hypoxemia, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Sedation during upper gastrointestinal endoscopy may lead to respiratory events not only during the procedure but also in the early recovery period. Although most hypoxemic episodes are considered transient, their frequency, duration, and clinical consequences during recovery remain insufficiently defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Sedated Upper Gastrointestinal Endoscopy
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2026to 20 Mar 2026
- Phase
- Observational
- 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
Study population: Adult patients undergoing elective upper gastrointestinal endoscopy (EGD) under anesthesiologist-administered sedation at a single tertiary care endoscopy unit. Participants will be enrolled consecutively and followed prospectively during the immediate recovery period without alteration of routine clinical management.
Who may be able to join
- Adults aged ≥18 years
- Scheduled for upper gastrointestinal endoscopy (EGD) under anesthesiologist-administered sedation
- Able to undergo post-procedure monitoring in the recovery unit
- Provided written informed consent for participation and data use
Who cannot join
- Colonoscopy or combined procedures (EGD + colonoscopy)
- Emergency procedures or procedures performed under intensive care conditions
- Requirement for endotracheal intubation, noninvasive ventilation, or advanced airway support during the procedure
- Known severe upper airway anatomical abnormalities, facial deformity, or tracheostomy
- Inability or refusal to provide informed consent
- Incomplete or unavailable recovery-period oxygen saturation monitoring data
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
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Incidence, Duration, and Clinical Impact of Recovery-Period Hypoxemia Following Sedated Upper Gastrointestinal Endoscopy: A Prospective Observational Study
Sedation during upper gastrointestinal endoscopy may lead to respiratory events not only during the procedure but also in the early recovery period. Although most hypoxemic episodes are considered transient, their frequency, duration, and clinical consequences during recovery remain insufficiently defined.
This prospective observational study aims to evaluate the incidence, duration, and clinical impact of recovery-period hypoxemia following sedated upper gastrointestinal endoscopy. Hypoxemia is defined as SpO₂ <90% lasting ≥10 seconds. Associated respiratory events and potential risk factors will be analyzed without altering routine clinical practice.
- Conditions
- Hypoxemia
- Being tested
- Sedated Upper Gastrointestinal Endoscopy
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedated Upper Gastrointestinal EndoscopyOther
Routine upper gastrointestinal endoscopy performed under anesthesiologist-administered sedation. No experimental intervention is applied; the study prospectively observes respiratory events during the recovery period as part of standard clinical care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery-Period Respiratory Events
Occurrence of respiratory events during the recovery period following sedated upper gastrointestinal endoscopy, defined as at least one of the following:
SpO₂ <90% lasting ≥10 seconds
Requirement for airway maneuver (jaw-thrust, chin-lift, OPA/NPA, mask ventilation)
Escalation or re-initiation of supplemental oxygen
Measured: From end of procedure (scope-out) until discharge from recovery unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start28 Feb 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445256
- Sponsor's protocol ID
- endoscopy rox index
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shirota Y, Hirase Y, Suda T, Miyazawa M, Hodo Y, Wakabayashi T. More than half of hypoxemia cases occurred during the recovery period after completion of esophagogastroduodenoscopy with planned moderate sedation. Sci Rep. 2020 Mar 9;10(1):4312. doi: 10.1038/s41598-020-61120-0.
PubMed 32152344Pozin IE, Zabida A, Nadler M, Zahavi G, Orkin D, Berkenstadt H. Respiratory complications during recovery from gastrointestinal endoscopies performed by gastroenterologists under moderate sedation. Clin Endosc. 2023 Mar;56(2):188-193. doi: 10.5946/ce.2022.033. Epub 2023 Jan 10.
PubMed 36624087
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Duration, and Clinical Impact of Recovery-Period Hypoxemia Following Sedated Upper Gastrointestinal Endoscopy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07445256
- Acronym / sponsor ID
- endoscopy rox index
- Conditions
- Hypoxemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 3 Mar 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.
Sedation during upper gastrointestinal endoscopy may lead to respiratory events not only during the procedure but also in the early recovery period. Although most hypoxemic episodes are considered transient, their frequency, duration, and clinical consequences during recovery remain insufficiently defined.
This prospective observational study aims to evaluate the incidence, duration, and clinical impact of recovery-period hypoxemia following sedated upper gastrointestinal endoscopy. Hypoxemia is defined as SpO₂ <90% lasting ≥10 seconds. Associated respiratory events and potential risk factors will be analyzed without altering routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective upper gastrointestinal endoscopy (EGD) under anesthesiologist-administered sedation at a single tertiary care endoscopy unit. Participants will be enrolled consecutively and followed prospectively during the immediate recovery period without alteration of routine clinical management.
Key inclusion criteria (4 listed)
- Adults aged ≥18 years
- Scheduled for upper gastrointestinal endoscopy (EGD) under anesthesiologist-administered sedation
- Able to undergo post-procedure monitoring in the recovery unit
- Provided written informed consent for participation and data use
Key exclusion criteria (6 listed)
- Colonoscopy or combined procedures (EGD + colonoscopy)
- Emergency procedures or procedures performed under intensive care conditions
- Requirement for endotracheal intubation, noninvasive ventilation, or advanced airway support during the procedure
- Known severe upper airway anatomical abnormalities, facial deformity, or tracheostomy
- Inability or refusal to provide informed consent
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 |
|---|---|---|
| Sedated Upper Gastrointestinal EndoscopyRoutine upper gastrointestinal endoscopy performed under anesthesiologist-administered sedation. No experimental intervention is applied; the study prospectively observes respiratory events during the recovery period as part of standard clinical care. | Other | – |
Primary outcome
Recovery-Period Respiratory Events
Time frame: From end of procedure (scope-out) until discharge from recovery unit
Occurrence of respiratory events during the recovery period following sedated upper gastrointestinal endoscopy, defined as at least one of the following: SpO₂ <90% lasting ≥10 seconds Requirement for airway maneuver (jaw-thrust, chin-lift, OPA/NPA, mask ventilation) Escalation or re-initiation of supplemental oxygen
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 3 Mar 2026.
- Results publication: PubMed 32152344Shirota Y, Hirase Y, Suda T, Miyazawa M, Hodo Y, Wakabayashi T. More than half of hypoxemia cases occurred during the recovery period after completion of esophagogastroduodenoscopy with planned moderate sedation. Sci Rep. 2020 Mar 9;10(1):4312. doi: 10.1038/s41598-020-61120-0.
- Results publication: PubMed 36624087Pozin IE, Zabida A, Nadler M, Zahavi G, Orkin D, Berkenstadt H. Respiratory complications during recovery from gastrointestinal endoscopies performed by gastroenterologists under moderate sedation. Clin Endosc. 2023 Mar;56(2):188-193. doi: 10.5946/ce.2022.033. Epub 2023 Jan 10.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia, run by Istinye University 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 6 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: opening soon, as of the sponsor's last update on 3 Mar 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 ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery-Period Respiratory Events (time frame: From end of procedure (scope-out) until discharge from recovery unit). 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 NCT07445256, which also lists 2 linked publications.
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 3 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.