Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

Hypoxia Clinical Trial

Official title:

Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03741998
• Other study ID #: RenJiH[2018]011
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2019
• Source: RenJi Hospital
• Contact: Diansan Su, Dr.
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For performing transnasal humidified rapid insufflation ventilatory exchange (THRIVE), jaw-thrust maneuver have to maintain to make sure the airway open and the CO2 clearance during apnoea. The objective of present study is to prove that nasopharyngeal airway facilitate THRIVE and no need jaw-thrust maneuver and maintain the similar PO2 and PCO2 during apnoea.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent.

• Undergoing surgery with general anaesthesia.

• Adult, >18 years old.

• American Society of Anesthesiology classification I-II.

Exclusion Criteria:

• Coagulation disorders or a tendency of nose bleeding

• An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months

• Severe aortic stenosis or mitral stenosis;

• Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;

• Acute myocardial infarction in the last 6 months;

• Acute arrhythmia (including both tachycardia and bradycardia) with hemodynamic instability;

• Diagnosed COPD or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);

• Increased intracranial pressure;

• ASA >II;

• Mouth, nose, or throat infection;

• Fever, defined as core body temperature > 37.5°C;

• Pregnancy, breastfeeding or positive pregnancy test;

• Emergency procedure.

• Patient with known or suspected difficult airway

Related Conditions & MeSH terms

• Hypercapnia
• Hypoxia

Intervention

Device:
• Nasopharyngeal airway
THRIVE with a regular nasopharyngeal airway.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The partial pressure of carbon dioxide (pCO2)		From start to end of THRIVE(20 minutes)
Primary	The partial pressure of oxygen(PO2)		From start to end of THRIVE(20 minutes)