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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

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.

Condition or disease Intervention/treatment Phase
Hypoxia Hypercapnia Device: Nasopharyngeal airway Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The partial pressure of carbon dioxide (pCO2) [ Time Frame: From start to end of THRIVE(20 minutes) ]
  2. The partial pressure of oxygen(PO2) [ Time Frame: From start to end of THRIVE(20 minutes) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741998


Contacts
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Contact: Diansan Su, Dr. +862168383702 diansansu@yahoo.com

Locations
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China, Shanghai
Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: diansan su, Dr.    +862168383702    diansansu@yahoo.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Director: Diansan Su, Dr. Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03741998     History of Changes
Other Study ID Numbers: RenJiH[2018]011
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoxia
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action