Exploratory study about risk factors of respiratory complications in invasive trans oral with combined use of exhaled CO2 concentration measurement and patient awakening measurement

Exploratory study about risk factors of respiratory complications in invasive trans oral with combined use of exhaled CO2 concentration measurement and patient awakening measurement - Exploratory study about risk factors of respiratory complications in invasive trans oral with combined use of exhaled CO2 concentration measurement and patient awakening measurement

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036269

Enrollment

100

Registered

2019-03-23

Start date

2019-03-23

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Upper gastrointestinal bleeding/tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who receive upper treatment endoscope, and provided informed consent for this study.

Exclusion criteria

Exclusion criteria: Patients who disagree with this study.

Design outcomes

Primary

Measure	Time frame
Hypoxemia (SpO2 <90% lasts more than 15 seconds)	—

Secondary

Measure	Time frame
Apnea (exhaled CO2 detection continues for more than 15 seconds),Vital abnormality(Hypotension (systolic blood pressure 90 mmHg or less lasts more than 1 minute), Bradycardia (50 pulses per minute or less lasting more than 1 minute)), Type of examination, Procedure related items (examination time, total sedative dose, total oxygen dose),Severe hypoxemia (SpO2 <85% lasts more than 15 seconds), Serious complications (pneumonia requiring oxygen administration, bleeding requiring blood transfusion, perforation of digestive tract etc.), Patient satisfaction (Numerical Rating Scale (NRS) 10 stages (questioned by nurse in recovery room after examination), cooperation of patients by implementation doctor evaluation (NRS 10 grade)	—

Measure

Time frame

Apnea (exhaled CO2 detection continues for more than 15 seconds),Vital abnormality(Hypotension (systolic blood pressure 90 mmHg or less lasts more than 1 minute), Bradycardia (50 pulses per minute or less lasting more than 1 minute)), Type of examination, Procedure related items (examination time, total sedative dose, total oxygen dose),Severe hypoxemia (SpO2 <85% lasts more than 15 seconds), Serious complications (pneumonia requiring oxygen administration, bleeding requiring blood transfusion, perforation of digestive tract etc.), Patient satisfaction (Numerical Rating Scale (NRS) 10 stages (questioned by nurse in recovery room after examination), cooperation of patients by implementation doctor evaluation (NRS 10 grade)

—

Countries

Japan

Contacts

Public ContactNaoki Hosoe

Keio University School of Medicine Center for Diagnostic and Therapeutic Endoscopy

nhosoe@keio.jp03-5363-3760

Outcome results