Nasotracheal IntubationNCT03853239
Nasal Ventilation vs Face Mask
A study testing face mask ventilation crossover nasal ventilation and nasal ventilation crossover face mask ventilation in people with Nasotracheal Intubation, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Nasotracheal intubation(NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck. While these patients showed higher rates of difficult laryngoscopy. Therefore, duration of apnoea is prolonged and re-oxygenation is inevitable.Mask ventilation is the most fundamental technique in maintaining… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Nasotracheal Intubation
- What is being tested?
- face mask ventilation crossover nasal ventilation and nasal ventilation crossover face mask ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Aug 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-55 years old
- ASA physical status I and II
- Requiring general anesthesia with nasal intubation
Who cannot join
- Respiratory disease，cardiovascular disease, cerebral vascular disease
- Anticipated Difficult Mask Ventilation(Age>55 years old, obesity,bearded,edentulous,a history of snoring)
- The need for emergency surgery
- Contraindications to nasal intubation
- Pregnancy
- Gastric-esophageal reflex or a full stomach
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Randomised, Crossover Comparison of Nasal Ventilation vs Face Mask in Anesthetised Adults
Nasotracheal intubation(NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck. While these patients showed higher rates of difficult laryngoscopy. Therefore, duration of apnoea is prolonged and re-oxygenation is inevitable.Mask ventilation is the most fundamental technique in maintaining oxygenation, even when endotracheal intubation is failed. However, the most common complication of NTI is epistaxis, removing the nasotracheal tube could make mask ventilation extremely difficult.So the investigatorsbelieve the ideal approach is ventilation through original nasotracheal tube.Several techniques of supraglottic ventilations through endotracheal tubes have been reported.It remains uncertain whether supraglottic ventilation through inflated nasal RAE endotracheal tube has similar efficiency as mask ventilation after general anesthesia induction. Based on previous clinical experience, the investigators hypothesised that ventilations through inflated nasal RAE endotracheal tube and through facemask were comparable in terms of tidal volume and airway pressure in anesthetized, apnoeic adults.
Forty patients were randomly assigned (sealed envelope method) to face mask（Group A，n=20）or nasal ventilation(Group B，n=20), For A: face mask ventilation followed by nasal ventilation and for B:nasal ventilation followed by face mask ventilation.Measure the tidal volume and air leakage of face mask and nasal ventilation during pressure-controlled ventilation mode and volume-controlled mode, respectively.
- Conditions
- Nasotracheal Intubation
- Being tested
- face mask ventilation crossover nasal ventilation, nasal ventilation crossover face mask ventilation
- Keywords
- face mask, nasal ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
face mask ventilation crossover nasal ventilationProcedure or surgery
Group A was first ventilated through the face mask, and the tidal volume was measured under pressure-controlled mode (10, 15, 20 cm H2O) ;Switched to volume-controlled (6,8,10ml/kg predicted body weight)mode, the actual tidal volume was recorded, and the air leakage was calculated. Then, put a nasal RAE tube in one side of the nostril, inflate the cuff, make the catheter in a natural position after inflation, clip the other side of the nostril, close the lip with tape, connect the breathing circuit, record the actual tidal volume; measure the expired tidal volume during pressure-controlled ventilation (10, 15, 20 cm H2O).Subject will start with one technique and then cross over to the other technique.
nasal ventilation crossover face mask ventilationProcedure or surgery
Group B first placed a nasal RAE tube in one side of the nostril, the cuff was inflated, the catheter was in a natural position after inflation, the other side of the nostril was clamped, the lip was closed with tape, the breathing circuit was connected, and the amount of tidal volume was measured under pressure-controlled mode ( 10,15,20cm H2O) ; switch to volume-controlled ventilation mode (6,8,10ml/kg predicted body weight), record the actual tidal volume; pull out the tracheal tube, perform mask ventilation, record the actual tidal volume and tidal volume under volume-controlled mode(6,8,10ml/kg predicted body weight) and pressure-controlled mode (10, 15, 20 cm H2O) , respectively.Subject will start with one technique and then cross over to the other technique.
| Study group | Role | What they receive |
|---|---|---|
| face mask crossover nasal ventilation | Active comparator | Not described Receives: Procedure: face mask ventilation crossover nasal ventilation |
| nasal ventilation crossover face mask | Active comparator | Not described Receives: Procedure: nasal ventilation crossover face mask ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in expired tidal volume of each technique under pressure-controlled mode
Measured: 3 breaths of expired tidal volume for each technique
Difference in air leakage of each technique under volume-controlled mode
Measured: 3 breaths of air leakage for each technique
Secondary outcomes (4)
number of participants with Oxygen Saturation- Reading Below 95%
Measured: intraoperative duration of each ventilation technique
peak inspiratory pressure
Measured: intraoperative duration of each ventilation technique
end tidal CO2 partial pressure Reading- Median
Measured: intraoperative duration of each ventilation technique
hemodynamic changes
Measured: intraoperative duration of each ventilation technique
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasotracheal IntubationStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853239
- Sponsor's protocol ID
- nasal ventilation vs face mask
- Status last verified
- Mar 2019
- First submitted
- 22 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Crossover Comparison of Nasal Ventilation vs Face Mask in Anesthetised Adults
- ClinicalTrials.gov ID
- NCT03853239
- Acronym / sponsor ID
- nasal ventilation vs face mask
- Conditions
- Nasotracheal Intubation
- Keywords
- face mask, nasal ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 25 Feb 2019 (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.
Nasotracheal intubation(NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck. While these patients showed higher rates of difficult laryngoscopy. Therefore, duration of apnoea is prolonged and re-oxygenation is inevitable.Mask ventilation is the most fundamental technique in maintaining oxygenation, even when endotracheal intubation is failed. However, the most common complication of NTI is epistaxis, removing the nasotracheal tube could make mask ventilation extremely difficult.So the investigatorsbelieve the ideal approach is ventilation through original nasotracheal tube.Several techniques of supraglottic ventilations through endotracheal tubes have been reported.It remains uncertain whether supraglottic ventilation through inflated nasal RAE endotracheal tube has similar efficiency as mask ventilation after general anesthesia induction. Based on previous clinical experience, the investigators hypothesised that ventilations through inflated nasal RAE endotracheal tube and through facemask were comparable in terms of tidal volume and airway pressure in anesthetized, apnoeic adults.
Forty patients were randomly assigned (sealed envelope method) to face mask（Group A，n=20）or nasal ventilation(Group B，n=20), For A: face mask ventilation followed by nasal ventilation and for B:nasal ventilation followed by face mask ventilation.Measure the tidal volume and air leakage of face mask and nasal ventilation during pressure-controlled ventilation mode and volume-controlled mode, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| face mask crossover nasal ventilation | Active comparator | Procedure: face mask ventilation crossover nasal ventilation |
| nasal ventilation crossover face mask | Active comparator | Procedure: nasal ventilation crossover face mask ventilation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-55 years old
- ASA physical status I and II
- Requiring general anesthesia with nasal intubation
Key exclusion criteria (6 listed)
- Respiratory disease，cardiovascular disease, cerebral vascular disease
- Anticipated Difficult Mask Ventilation(Age>55 years old, obesity,bearded,edentulous,a history of snoring)
- The need for emergency surgery
- Contraindications to nasal intubation
- Pregnancy
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 |
|---|---|---|
| face mask ventilation crossover nasal ventilationGroup A was first ventilated through the face mask, and the tidal volume was measured under pressure-controlled mode (10, 15, 20 cm H2O) ;Switched to volume-controlled (6,8,10ml/kg predicted body weight)mode, the actual tidal volume was recorded, and the air leakage was calculated. Then, put a nasal RAE tube in one side of the nostril, inflate the cuff, make the catheter in a natural position after inflation, clip the other side of the nostril, close the lip with tape, connect the breathing circuit, record the actual tidal volume; measure the expired tidal volume during pressure-controlled ventilation (10, 15, 20 cm H2O).Subject will start with one technique and then cross over to the other technique. | Procedure or surgery | face mask crossover nasal ventilation |
| nasal ventilation crossover face mask ventilationGroup B first placed a nasal RAE tube in one side of the nostril, the cuff was inflated, the catheter was in a natural position after inflation, the other side of the nostril was clamped, the lip was closed with tape, the breathing circuit was connected, and the amount of tidal volume was measured under pressure-controlled mode ( 10,15,20cm H2O) ; switch to volume-controlled ventilation mode (6,8,10ml/kg predicted body weight), record the actual tidal volume; pull out the tracheal tube, perform mask ventilation, record the actual tidal volume and tidal volume under volume-controlled mode(6,8,10ml/kg predicted body weight) and pressure-controlled mode (10, 15, 20 cm H2O) , respectively.Subject will start with one technique and then cross over to the other technique. | Procedure or surgery | nasal ventilation crossover face mask |
Primary outcome
Difference in expired tidal volume of each technique under pressure-controlled mode
Time frame: 3 breaths of expired tidal volume for each technique
Difference in air leakage of each technique under volume-controlled mode
Time frame: 3 breaths of air leakage for each technique
4 secondary outcomes
number of participants with Oxygen Saturation- Reading Below 95%
Time frame: intraoperative duration of each ventilation technique
peak inspiratory pressure
Time frame: intraoperative duration of each ventilation technique
end tidal CO2 partial pressure Reading- Median
Time frame: intraoperative duration of each ventilation technique
hemodynamic changes
Time frame: intraoperative duration of each ventilation technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing face mask ventilation crossover nasal ventilation and nasal ventilation crossover face mask ventilation in people with Nasotracheal Intubation, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 3 inclusion and 6 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 7 Mar 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 Yu Sun, MD,PhD (0086-136-1189-5542, dr_sunyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in expired tidal volume of each technique under pressure-controlled mode (time frame: 3 breaths of expired tidal volume for each technique). 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?
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 7 Mar 2019.