Study on the use of high-flow oxygen to improve the safety of high-risk patients during sedated digestive endoscopies

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitario Rio Hortega

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-06-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Spanish Foundation for Digestive Endoscopy/Fundación Española de Endoscopia Digestiva (FSEED)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the effectiveness of administering high-flow medical oxygen during digestive endoscopic procedures under deep sedation in order to reduce episodes of hypoxemia.

Secondary objectives 1

1. To know and compare between both groups: The number of hypoxemic episodes per procedure The incidence of mild-to-moderate hypoxemia (90–80%) and severe hypoxemia (<80%) The mean duration of hypoxemic episodes during the procedure The minimum peripheral oxygen saturation (SpO₂) during the procedure The incidence of hypercapnia The need for minor airway rescue maneuvers: chin lift/jaw thrust or insertion of a Guedel (oropharyngeal) airway The need for major resuscitation maneuvers: bag-valve-mask ventilation (Ambu) and orotracheal intubation The need for anesthesiologist intervention during the endoscopic procedure under deep sedation due to complications The need to permanently discontinue the endoscopic procedure due to sedation-related complications The need to discontinue HFNO or conventional oxygen therapy due to patient intolerance To record any other complications that may occur

Conditions and MedDRA coding

Hypoxemic episodes in patients undergoing gastroscopy, colonoscopy, or oral endoscopic ultrasound under deep sedation with oxygen therapy administration.

Regulatory references

Plan to share IPD

Yes

IPD plan description

All information obtained during the study will be kept confidential. Neither you nor your data will be individually identifiable in any report derived from the study. These data will be included anonymously in a prospective registry and will be handled in accordance with Organic Law 3/2018 of 5 December on the Protection of Personal Data. You will have the rights recognized under this law, including the rights of access, rectification, objection, and erasure. All information collected during the study will be treated as confidential. Neither you nor your data will be individually identifiable in any report or publication derived from the study. The data will be included anonymously in a prospective registry and processed in accordance with Organic Law 3/2018 on the Protection of Personal Data. You have the rights of access, rectification, objection, erasure, restriction of processing, and data portability, and you may withdraw your consent at any time, although this may result in your

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Age ≥ 18 years Signed informed consent Obesity (BMI ≥ 30 kg/m²) ASA physical status III Stable pulmonary disease (no hospital admission within the previous 6 months) Stable heart failure (no hospital admission within the previous 6 months) Diagnosed obstructive sleep apnea or suspected OSA defined as a STOP-Bang score ≥ 3 (Appendix II) History of sedation-related complications during a previous endoscopic procedure under deep sedation

Exclusion criteria 1

1. ASA physical status IV Acute decompensated or unstable heart failure at the time of endoscopy (hospital admission within the previous 6 months) Acute exacerbation or unstable respiratory disease at the time of endoscopy (hospital admission within the previous 6 months) Pregnant women Use of long-term home oxygen therapy Patients with orotracheal intubation Tracheostomized patients Known allergy to propofol or contraindication to its use

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of hypoxemia, capnography waveform abnormalities, bradycardia, hypotension, arrhythmias, pulmonary aspiration, and cardiorespiratory arrest.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario Rio Hortega

Sponsor organisation

Hospital Universitario Rio Hortega

Address

Calle Dulzaina 2

City

Valladolid

Postcode

47012

Country

Spain

Scientific contact point

Organisation

Hospital Universitario Rio Hortega

Contact name

Pilar Diez Redondo

Public contact point

Organisation

Hospital Universitario Rio Hortega

Contact name

Pilar Diez Redondo

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications