Back to resultsNasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Primary Purpose
Hypoxia, Hypercapnia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nasopharyngeal airway
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia
Eligibility Criteria
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
Sites / Locations
- Renji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
THRIVE
THRIVE with nasopharyngeal airway
Arm Description
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction using jaw-thrust maneuver.
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction with nasopharyngeal airway.
Outcomes
Primary Outcome Measures
The partial pressure of carbon dioxide (pCO2)
The partial pressure of oxygen(PO2)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03741998
Brief Title
Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Official Title
Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypercapnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
THRIVE
Arm Type
No Intervention
Arm Description
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction using jaw-thrust maneuver.
Arm Title
THRIVE with nasopharyngeal airway
Arm Type
Active Comparator
Arm Description
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction with nasopharyngeal airway.
Intervention Type
Device
Intervention Name(s)
Nasopharyngeal airway
Intervention Description
THRIVE with a regular nasopharyngeal airway.
Primary Outcome Measure Information:
Title
The partial pressure of carbon dioxide (pCO2)
Time Frame
From start to end of THRIVE(20 minutes)
Title
The partial pressure of oxygen(PO2)
Time Frame
From start to end of THRIVE(20 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
Official's Role
Study Director
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
diansan su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33330535
Citation
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.
Results Reference
derived
Learn more about this trial
Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
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