Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

NCT03741998 | Unknown DMC

• 1 other identifier: RenJiH[2018]011
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia; Hypercapnia

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

THRIVE

NO INTERVENTION

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction using jaw-thrust maneuver.

THRIVE with nasopharyngeal airway

ACTIVE COMPARATOR

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction with nasopharyngeal airway.

Device: Nasopharyngeal airway

Interventions

Nasopharyngeal airway DEVICE

THRIVE with a regular nasopharyngeal airway.

THRIVE with nasopharyngeal airway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Undergoing surgery with general anaesthesia.
• Adult, \>18 years old.
• American Society of Anesthesiology classification I-II.

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33330535 DERIVED

MeSH Terms

Conditions

Hypoxia; Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diansan Su, Dr.

  Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

  STUDY DIRECTOR

Central Study Contacts

Diansan Su, Dr.

CONTACT

+862168383702; diansansu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: November 7, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

CN (1)