Noninvasive airway devices for the prevention of intra-procedural hypoxemia in obese patients undergoing an upper endoscopy with propofol sedation by a non-anesthesiologist-provider - a randomized controlled trial

Noninvasive airway devices for the prevention of intra-procedural hypoxemia in obese patients undergoing an upper endoscopy with propofol sedation by a non-anesthesiologist-provider - a randomized controlled trial - NasHorN

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035779

Enrollment

Registered

2024-12-19

Start date

2025-01-20

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and obese individuals undergoing upper endoscopy under propofol sedation

Interventions

Group 1: Group A: Standard 2 l/min O2 with nasal cannula Group 2: Group B: Nasal PAP mask (SuperNO2VA™) with 8 L/min O2 with valve in the "open" position

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Elective upper endoscopy or a combination of upper and lower endoscopy under sedation Expected procedure duration 90% on room air upon arrival at the endoscopy department

Exclusion criteria

Exclusion criteria: Tracheostoma BMI 40 kg/m² ASA IV or V ASA III and particularly high sedation risk, requiring the involvement of an anesthesia team Severe lung disease (at the discretion of the medical team, e.g., need for continuous O2 supplementation) Expected procedure duration >1 hour Pregnancy Inability to consent Contraindications to the use of propofol Additional use of sedatives other than propofol Diagnosed obstructive sleep apnea syndrome (OSAS) and home CPAP therapy

Design outcomes

Primary

Measure	Time frame
Intra-procedural drop in SpO2 i.e. delta between baseline SpO2 before initiation of sedation and lowest SpO2 at any time during sedation	—

Secondary

Measure	Time frame
• Hypoxemia below 90% continuously for >10 seconds during sedation • Hypoxemia below 80% uninterrupted for >10 seconds during sedation • Minor respiratory interventions (jaw thrust, Esmarch maneuver, increasing O2 flow rate, nasopharyngeal or oropharyngeal airway) • Major respiratory interventions (mask-and-bag ventilation, endotracheal intubation) • Maximum CO2 during the examination • Amount of propofol used per minute • Drop in blood pressure (Baseline MAP vs. lowest MAP recorded during sedation) • Other adverse events • Examination time • Recovery time • Level of Patient Comfort (Visual analogue scale) • Level of Examiner Comfort (Visual analogue scale) • Level of Nurse Comfort (Visual analogue scale)	—

Measure

Time frame

• Hypoxemia below 90% continuously for >10 seconds during sedation • Hypoxemia below 80% uninterrupted for >10 seconds during sedation • Minor respiratory interventions (jaw thrust, Esmarch maneuver, increasing O2 flow rate, nasopharyngeal or oropharyngeal airway) • Major respiratory interventions (mask-and-bag ventilation, endotracheal intubation) • Maximum CO2 during the examination • Amount of propofol used per minute • Drop in blood pressure (Baseline MAP vs. lowest MAP recorded during sedation) • Other adverse events • Examination time • Recovery time • Level of Patient Comfort (Visual analogue scale) • Level of Examiner Comfort (Visual analogue scale) • Level of Nurse Comfort (Visual analogue scale)

—

Countries

Germany

Contacts

Public ContactThomas von Hahn

Asklepios Klinik Barmbek

t.hahn@asklepios.com+49 (040) 181882-38

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026