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Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

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ClinicalTrials.gov Identifier: NCT03741998
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE November 7, 2018
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • The partial pressure of carbon dioxide (pCO2) [ Time Frame: From start to end of THRIVE(20 minutes) ]
  • The partial pressure of oxygen(PO2) [ Time Frame: From start to end of THRIVE(20 minutes) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03741998 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Official Title  ICMJE Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypoxia
  • Hypercapnia
Intervention  ICMJE Device: Nasopharyngeal airway
THRIVE with a regular nasopharyngeal airway.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Nasopharyngeal airway
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Diansan Su, Dr. +862168383702 diansansu@yahoo.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03741998
Other Study ID Numbers  ICMJE RenJiH[2018]011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party RenJi Hospital
Study Sponsor  ICMJE RenJi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Diansan Su, Dr. Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
PRS Account RenJi Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP