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Design and Clinical Application of New Endoscopic Nasal Mask

Design and Clinical Application of New Endoscopic Nasal Mask

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004086
Enrollment
Unknown
Registered
2013-09-08
Start date
2014-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Hyoxemia

Interventions

Grope A2 of painless gastroscopy:Provide oxygen by nasal catheter
Grope A2 of painless gastroscopy:Participants aged 65-80
Grope B1 of painless gastroscopy:Provide oxygen by new endoscopic nasal mask
Grope B1 of painless gastroscopy:Participants aged 45-64
Grope B2 of painless gastroscopy:Provide oxygen by new endoscopic nasal mask
Grope B2 of painless gastroscopy:Participants aged 65-80
Grope A of awake fiberoptic nasotracheal intubatio:Provide oxygen by nasal catheter
Grope B of awake fiberoptic nasotracheal intubatio:Provide oxygen by new endoscopic nasal mask

Sponsors

Tongji Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Painless gastroscopy: (1) ASA (American society anesthesiologists) I-II; (2) The age 45-80 years old; (3) No serious cardiopulmonary kidney disease; (4) Fast for 12 hours before checking; (5) BMI<=25. 2. Awake nasal fiberoptic bronchoscopy tracheal intubation: (1) Mouth disorder; (2) Respiratory obstruction; (3) Stiff neck; (4) The cervical spine fracture dislocation; (5) The anterior cervical scar contracture; (6) The Adam's apple is too high; (7) The neck thick short and mandibular retraction (micrognathia) patients.

Exclusion criteria

Exclusion criteria: 1. Painless gastroscopy: (1) Serious coronary heart disease and myocardial injury with serious heart failure; (2) The stenosis of the esophagus or cardia obstruction; (3) The aortic aneurysm; (4) Hemorrhagic shock; (5) The acute pharyngitis and tonsillitis; (6) pneumonia or other infectious fever; (7) The asthmatic breathing difficulties; (8) The severe pulmonary dysfunction; (9) Physical extreme weakness; (10) The patients not cooperate or spirit is not normal; (11) Acute upper gastrointestinal bleeding; (12) Allergic to propofol or the emulsifier content; (13) Pregnancy and lactation women; (14) Severe sleep apnea syndrome. 2. Awake nasal fiberoptic bronchoscopic tracheal intubation: (1) Airway tumor, airway anatomic abnormalities, airway injuries; (2) Coagulation abnormalities, who are taking anticoagulant drugs; (3) Skull fracture; The giant aneurysm; Acute inflammation of the larynx; (4) Pregnancy and lactation women.

Design outcomes

Primary

MeasureTime frame
Surplus pulse O2;Time consuming of trachea cannula;The number of attempts to intubation;Time consuming of Painless gastroscopy;Dosage of propofol;Arrhythmia;

Secondary

MeasureTime frame
Respiration;Blood pressure;Heart rate;Pulse;

Countries

China

Contacts

Public ContactYu Bin

Tongji Hospital of Shanghai

yubin@tongji.edu.cn+86 13918108880

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 9, 2026