Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

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.

Study Overview

• Status: Unknown
• Conditions: Hypoxia; Hypercapnia
• Intervention / Treatment: Device: Nasopharyngeal airway

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: THRIVE; Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction using jaw-thrust maneuver.
Active Comparator: THRIVE with nasopharyngeal airway; Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction with nasopharyngeal airway.	Device: Nasopharyngeal airway; THRIVE with a regular nasopharyngeal airway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The partial pressure of carbon dioxide (pCO2)	From start to end of THRIVE(20 minutes)
The partial pressure of oxygen(PO2)	From start to end of THRIVE(20 minutes)

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Director: Diansan Su, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

Publications and helpful links

General Publications

• Chen L, Yang L, Tian W, Zhang X, Zhao Y, Huang L, Tian J, Zhang J, Wu J, Yu W, Su D. Transnasal Humidified Rapid Insufflation Ventilatory Exchange With Nasopharyngeal Airway Facilitates Apneic Oxygenation: A Randomized Clinical Noninferiority Trial. Front Med (Lausanne). 2020 Nov 27;7:577891. doi: 10.3389/fmed.2020.577891. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Hypercapnia
• Other Study ID Numbers: RenJiH[2018]011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No