HypoxiaNCT03741998
Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
A study testing Nasopharyngeal airway in people with Hypoxia and Hypercapnia, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia, Hypercapnia
- What is being tested?
- Nasopharyngeal airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Undergoing surgery with general anaesthesia.
- Adult, >18 years old.
- American Society of Anesthesiology classification I-II.
Who cannot join
- 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;
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
diansan su, Dr., +862168383702, diansansu@yahoo.com
About this study
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
- Being tested
- Nasopharyngeal airway
- Medical subject headings
- Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal airwayDevice
THRIVE with a regular nasopharyngeal airway.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Nasopharyngeal airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
The partial pressure of carbon dioxide (pCO2)
Measured: From start to end of THRIVE(20 minutes)
The partial pressure of oxygen(PO2)
Measured: From start to end of THRIVE(20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start7 Nov 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diansan Su, Dr., Study director, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741998
- Sponsor's protocol ID
- RenJiH[2018]011
- Status last verified
- Jul 2019
- First submitted
- 12 Nov 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33330535
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
- ClinicalTrials.gov ID
- NCT03741998
- Acronym / sponsor ID
- RenJiH[2018]011
- Conditions
- Hypoxia, Hypercapnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE | No intervention | –Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction using jaw-thrust maneuver. |
| THRIVE with nasopharyngeal airway | Active comparator | Device: Nasopharyngeal airwayTransnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction with nasopharyngeal airway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent.
- Undergoing surgery with general anaesthesia.
- Adult, >18 years old.
- American Society of Anesthesiology classification I-II.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal airwayTHRIVE with a regular nasopharyngeal airway. | Device | THRIVE with nasopharyngeal airway |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Derived from this study: PubMed 33330535Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diansan Su, Dr. study director
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal airway in people with Hypoxia and Hypercapnia, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Dr. (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The partial pressure of carbon dioxide (pCO2) (time frame: From start to end of THRIVE(20 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.