Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

NCT ID: NCT03741998

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2019-12-30

Brief Summary

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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

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Conditions

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Hypoxia Hypercapnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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THRIVE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

THRIVE with nasopharyngeal airway

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

Group Type ACTIVE_COMPARATOR

Nasopharyngeal airway

Intervention Type DEVICE

THRIVE with a regular nasopharyngeal airway.

Interventions

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Nasopharyngeal airway

THRIVE with a regular nasopharyngeal airway.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diansan Su, Dr.

Role: STUDY_DIRECTOR

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

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Diansan Su, Dr.

Role: CONTACT

+862168383702

Facility Contacts

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diansan su, Dr.

Role: primary

+862168383702

References

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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.

Reference Type DERIVED
PMID: 33330535 (View on PubMed)

Other Identifiers

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RenJiH[2018]011

Identifier Type: -

Identifier Source: org_study_id

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