Sedative, Hypnotic, or Anxiolytic WithdrawalNCT04924621

Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways

A study testing Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc., Mask ventilation and Midazolam(T group) in people with Sedative, Hypnotic, or Anxiolytic Withdrawal and Airway Control, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Sedative, Hypnotic, or Anxiolytic Withdrawal, Airway Control
What is being tested?: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc., Mask ventilation and Midazolam(T group)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteChina
Study dates: 10 Jun 2021to 10 Jun 2022
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 18-60
Patients with difficult airway assessed by two anesthesiologists according to the difficult airway score who needed to undergo nasal endotracheal intubation for oral and maxillofacial surgery in Peking University Stomatological Hospital.
BMI between 18 to 30 kg/m2
ASA Grade I to II
NYHA grade I
Patients requiring arterial hemodynamics monitoring and blood gas analysis due to surgical requirements
Signed the informed consent

Who cannot join

Respiratory diseases: respiratory failure, COPD, pulmonary fibrosis, asthma and other diseases. Patients with ventilatory dysfunction or airway obstruction.
NYHA cardiac function grade greater than I, or NYHA cardiac function grade I but with a history of coronary heart disease.
Conditions affecting the monitoring of peripheral oxygen saturation, such as poor peripheral circulation perfusion and application of vasoconstrictor, are present.
Indoor oxygen saturation below 92%.
Patients who cannot tolerate rapid exchange ventilation with nasal humidification.
Patients with a history of easy nasal bleeding.

Show all 10Show fewer

Inability to understand or express pain scores.
Menstrual period and lactation period of female patients.
The patient has mental illness.
Patients with severe intraoperative complications should be removed after surgery

Trial locations and contacts

1 site in 1 country.

Xudong Yang, MD contact

62179977

kqyangxudong@163.com

China1 site, 1 recruiting

Peking University Hospital of Stomatology
Beijing, Beijing Municipality, 100081
Xudong Yang, MD, 62179977, kqyangxudong@163.com
Zijian Guo, MS, 62179977, guozijian1993@126.com
Recruiting

Other trials in China

About this study

Official title: Conventional Sedation Compaired With THRIVE Under General Anesthesia in Endotracheal Intubation by Fiberbronchoscope in Patients With Difficult Airways，A Randomized Controlled Study

To compare the difference in endotracheal intubation in participants with difficult airway between under general anesthesia by Transnasal Humidified Rapid-Insufflation Ventilatory Exchange and under traditional sedation by mask ventilation. The investigators focus on the different outcomes in oxygenation maintaince, carbon dioxide removal and the effectiveness of safety apnea time, to evaluate the safety of receiving endotracheal intubation under general anesthesia in participants with difficult airway.

Conditions: Sedative, Hypnotic, or Anxiolytic Withdrawal, Airway Control
Being tested: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc., Mask ventilation, Midazolam(T group), Sufentani(T group), Propofol(T group)
Keywords: Moderate Sedative, Airway Control, THRIVE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.Device
The nasal cavity was disinfected with Iodophor cotton swab, and the appropriate nasal cavity was selected for endotracheal intubation assisted by fiberoptic bronchoscope according to the experience of anesthesiologists.
After the endotracheal intubation was fixed, the anesthesia machine was connected for mechanical ventilation. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg.
Mask ventilationDevice
The Control Group will receive sequential intravenous infusion of Sufentanil 5ug, midazolam 0.05mg/kg, and propofol 1-2ug/ml, to make the BIS between 70 and 80. 2ml tetracaine was injected with cyclothyroid membrane puncture, and the nasal cavity was disinfected with iodophor cotton swab. According to the experience of anesthesiologists, the appropriate nasal cavity was selected for intranasal endotracheal intubation assisted by fiberbronchoscope. After the endotracheal intubation was successful, the anesthesia machine was connected for mechanical ventilation, full narcotic inducer will be injected. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg.
Midazolam(T group)Drug
Midazolam 0.05mg/kg, intravenous injection
Sufentani(T group)Drug
Sufentanil 0.02-0.05ug/kg, intravenous injection
Propofol(T group)Drug
Propofol 2-3ug/ml, intravenous injection
Rocuronium(T group)Drug
Rocuronium 0.06mg/kg, intravenous injection
Drug use target(T group)Drug
Make BIS < 60 .
Sufentanil(C group)Drug
Sufentanil 5ug, intravenous injection
Midazolam(C group)Drug
Midazolam 0.05mg/kg, intravenous injection
PropofolDrug
Propofol 1-2ug/ml, intravenous injection
Tetracaine(C group)Drug
2ml tetracaine was injected with cyclothyroid membrane puncture.
Drug use targetDrug
Make the BIS between 70 and 80.

Study groups in NCT04924621
Study group	Role	What they receive
THRIVE group	Experimental	Patients in group T received mask ventilation(oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes, and then THRIVE device (device model: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher \& Paykel Healthcare, Inc.) was set 100% oxygen, flow rate 30L /min, temperature 34℃. Receives: Device: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.; Drug: Midazolam(T group); Drug: Sufentani(T group); Drug: Propofol(T group); Drug: Rocuronium(T group); Drug: Drug use target(T group)
Control group	Placebo comparator	The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes Receives: Device: Mask ventilation; Drug: Sufentanil(C group); Drug: Midazolam(C group); Drug: Propofol; Drug: Tetracaine(C group); Drug: Drug use target

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood oxygen pressure
Blood oxygen pressure after intubation immediately.
Measured: Day 0
Pulse oxygen saturation
Pulse oxygen saturation after intubation immediately.
Measured: Day 0
Blood carbon dioxide pressure
Blood carbon dioxide pressure after intubation immediately.
Measured: Day 0

Secondary outcomes (7)

Endtidal CO2
Endtidal CO2 at time point of TA、TB、TC、TD
Measured: Day 0
Success of intubation
Proportion of successful endotracheal intubation
Measured: Day 0
Arrhythmias or dramatic haemodynamic fluctuations
Arrhythmias and dramatic fluctuations in heart rate and blood pressure: types and times of arrhythmias in the test were recorded. Changes in heart rate and blood pressure more than 30% before surgery were recorded as dramatic fluctuations.
Measured: Day 0
Tolerance of intubation
The score of patient's tolerance to endotracheal intubation one day after surgery (0-10 points, 0 point is completely intolerable, 10 point is completely intolerable)
Measured: Day 1
Time to complete intubation
Time required to complete endotracheal intubation
Measured: Day 0
SPO2 below 95%
Percentage of patients with pulse oxygen saturation below 95% during the trial
Measured: Day 0
SPO2 below 92%
Percentage of patients with pulse oxygen saturation below 92% during the trial
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202110 Jun 2022

First posted14 Jun 2021
Study start10 Jun 2021
Primary completion10 May 2022 (estimated)
Study completion10 Jun 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sedative, Hypnotic, or Anxiolytic WithdrawalStudies of the same condition, open and under way.
More trials run by Peking UniversityThe 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 42 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04924621
Sponsor's protocol ID: PKUSSIRB-202163045
Status last verified: Apr 2022
First submitted: 7 Jun 2021
Last updated: 12 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Conventional Sedation Compaired With THRIVE Under General Anesthesia in Endotracheal Intubation by Fiberbronchoscope in Patients With Difficult Airways，A Randomized Controlled Study
ClinicalTrials.gov ID: NCT04924621
Acronym / sponsor ID: PKUSSIRB-202163045
Conditions: Sedative, Hypnotic, or Anxiolytic Withdrawal, Airway Control
Keywords: Moderate Sedative, Airway Control, THRIVE
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 42 participants (estimated)
Lead sponsor: Peking UniversityUniversity, hospital or other
Study start: 10 Jun 2021 (actual)
Primary completion: 10 May 2022 (estimated)
Study completion: 10 Jun 2022 (estimated)
First posted: 14 Jun 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
THRIVE group	Experimental	Device: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc., Drug: Midazolam(T group), Drug: Sufentani(T group), Drug: Propofol(T group), Drug: Rocuronium(T group), Drug: Drug use target(T group)Patients in group T received mask ventilation(oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes, and then THRIVE device (device model: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher \& Paykel Healthcare, Inc.) was set 100% oxygen, flow rate 30L /min, temperature 34℃.
Control group	Placebo comparator	Device: Mask ventilation, Drug: Sufentanil(C group), Drug: Midazolam(C group), Drug: Propofol, Drug: Tetracaine(C group), Drug: Drug use targetThe Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Age 18-60
Patients with difficult airway assessed by two anesthesiologists according to the difficult airway score who needed to undergo nasal endotracheal intubation for oral and maxillofacial surgery in Peking University Stomatological Hospital.
BMI between 18 to 30 kg/m2
ASA Grade I to II
NYHA grade I

Key exclusion criteria (10 listed)

Respiratory diseases: respiratory failure, COPD, pulmonary fibrosis, asthma and other diseases. Patients with ventilatory dysfunction or airway obstruction.
NYHA cardiac function grade greater than I, or NYHA cardiac function grade I but with a history of coronary heart disease.
Conditions affecting the monitoring of peripheral oxygen saturation, such as poor peripheral circulation perfusion and application of vasoconstrictor, are present.
Indoor oxygen saturation below 92%.
Patients who cannot tolerate rapid exchange ventilation with nasal humidification.

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
Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.The nasal cavity was disinfected with Iodophor cotton swab, and the appropriate nasal cavity was selected for endotracheal intubation assisted by fiberoptic bronchoscope according to the experience of anesthesiologists. After the endotracheal intubation was fixed, the anesthesia machine was connected for mechanical ventilation. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg.	Device	THRIVE group
Mask ventilationThe Control Group will receive sequential intravenous infusion of Sufentanil 5ug, midazolam 0.05mg/kg, and propofol 1-2ug/ml, to make the BIS between 70 and 80. 2ml tetracaine was injected with cyclothyroid membrane puncture, and the nasal cavity was disinfected with iodophor cotton swab. According to the experience of anesthesiologists, the appropriate nasal cavity was selected for intranasal endotracheal intubation assisted by fiberbronchoscope. After the endotracheal intubation was successful, the anesthesia machine was connected for mechanical ventilation, full narcotic inducer will be injected. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg.	Device	Control group
Midazolam(T group)Midazolam 0.05mg/kg, intravenous injection	Drug	THRIVE group
Sufentani(T group)Sufentanil 0.02-0.05ug/kg, intravenous injection	Drug	THRIVE group
Propofol(T group)Propofol 2-3ug/ml, intravenous injection	Drug	THRIVE group
Rocuronium(T group)Rocuronium 0.06mg/kg, intravenous injection	Drug	THRIVE group
Drug use target(T group)Make BIS < 60 .	Drug	THRIVE group
Sufentanil(C group)Sufentanil 5ug, intravenous injection	Drug	Control group
Midazolam(C group)Midazolam 0.05mg/kg, intravenous injection	Drug	Control group
PropofolPropofol 1-2ug/ml, intravenous injection	Drug	Control group
Tetracaine(C group)2ml tetracaine was injected with cyclothyroid membrane puncture.	Drug	Control group
Drug use targetMake the BIS between 70 and 80.	Drug	Control group

Primary outcome

Blood oxygen pressure
Time frame: Day 0
Blood oxygen pressure after intubation immediately.
Pulse oxygen saturation
Time frame: Day 0
Pulse oxygen saturation after intubation immediately.
Blood carbon dioxide pressure
Time frame: Day 0
Blood carbon dioxide pressure after intubation immediately.

7 secondary outcomes

Endtidal CO2
Time frame: Day 0
Success of intubation
Time frame: Day 0
Arrhythmias or dramatic haemodynamic fluctuations
Time frame: Day 0
Tolerance of intubation
Time frame: Day 1
Time to complete intubation
Time frame: Day 0
SPO2 below 95%
Time frame: Day 0
SPO2 below 92%
Time frame: Day 0

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
Individual participant dataSharing planned: No

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.

Xudong Yang, MD contact

62179977

kqyangxudong@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 10 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 12 Apr 2022. 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. Some participants in this study may receive a placebo. 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 Xudong Yang, MD (62179977, kqyangxudong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood oxygen pressure (time frame: Day 0). The study lists 3 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 NCT04924621.

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 12 Apr 2022.