Nasotracheal IntubationNCT02993692
Nasotracheal Intubation in Children for Outpatient Dental Surgery
A study testing Direct laryngoscopy and fiberoptic bronchoscopy in people with Nasotracheal Intubation, run by Inonu University.
Trial summary
The aim of study was to compare the hemodynamic responses and adverse events associated with nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct laryngoscope (DLS) in children undergoing general anesthesia for outpatient dental surgery. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasotracheal Intubation
- What is being tested?
- Direct laryngoscopy and fiberoptic bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 4 Apr 2017
- 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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA physical status of I-II, had a Mallampati Score of 1-2, were aged 5-15 years, were scheduled to undergo outpatient dental surgery under general anesthesia
Who cannot join
- The patient's refusal for study consent, active upper respiratory infection, airway abnormalities, nasal mass or nasal injury, bleeding disorders, allergies to anesthetics, uncontrolled hypertension, morbid obesity, hepatic or renal failure, cardiovascular diseases, a history of nasopharyngeal surgery and those who were difficult to intubate.
About this study
Official title: Nasotracheal Intubation in Children for Outpatient Dental Surgery: Is Fiberoptic Bronchoscopy Useful?
The aim of study was to compare the hemodynamic responses and adverse events associated with nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct laryngoscope (DLS) in children undergoing general anesthesia for outpatient dental surgery. Eighty children (aged 5-15 years) were scheduled to undergo outpatient dental surgery under general anesthesia and who required nasotracheal intubation were included.
Read the detailed description
Investigators obtained confirmation from the Inonu University Medical Faculty Hospital Ethics Committee (2015/101) and written informed consent from the guardians of all 80 children. These children, who had a American Society of Anesthesia physical status of I-II, had a Mallampati Score of 1-2, were aged 5-15 years, were scheduled to undergo outpatient dental surgery under general anesthesia, and required nasotracheal intubation were included in this prospective and randomized study. Exclusion criteria included the following: the patient's refusal for study consent, active upper respiratory infection, airway abnormalities, nasal mass or nasal injury, bleeding disorders, allergies to anesthetics, uncontrolled hypertension, morbid obesity, hepatic or renal failure, cardiovascular diseases, a history of nasopharyngeal surgery and those who were difficult to intubate. Children were randomly assigned into the direct laryngoscopy group (n = 40) or the fiberoptic bornchoscopy group (n = 40) according to a computer-randomized table. General anesthesia was administered to children due to the learning difficulties. The number of models was decided by a statistical power analysis after the conclusions from the pretest were obtained. All children fasted at least for 6 h before surgery, and the oral intake of clear fluids was restricted for 2-3 h. Premedication of midazolam (0.5 mg/kg) was orally administered in apple juice (0.5 mL/kg of body weight) 1 h prior to anesthesia. After being admitted to the operating room, the patient's systolic blood pressure (SBP) and heart rate (HR) were continually monitored with a multichannel physiologic monitor and the baseline values for SBP and HR were recorded. Thirty min before the intubation attempt, the nasal mucosa of both nostrils were anesthetized with a topical vasoconstrictor (0.05% xylometazoline spray, and 2% lidocaine 1 mL two times in each nostril) (9) to attenuate cardiovascular responses and adverse events in all children. Anesthesia was induced with 8% sevoflurane with eight deep breaths via a face mask, and the patient was maintained on 4% end-tidal sevoflurane, fentanyl 2 µr/kg and rocuronium 0.6 mg/kg. NTI was achieved 2 min after rocuronium injection. The more patent nostril was selected for intubation. An experienced anesthetist performed all intubations in the study and an assistant applied the maneuvers (jaw trust) and evaluated the patient during the postoperative visits. All NTIs, both DLS and FOB, were conducted by the same experienced anesthetist (the anesthetist had performed DLS and the FOB nasal intubation in more than 150 patients, including in at least 100 children before the study). A study nurse documented the anesthetic data and timing. In the DLS group, the spiral tube was inserted into the nose and intubated with a Macintosh laryngoscope according to conventional procedures using Magill forceps. In the FOB group, NTI was conducted using an FOB with an outer diameter of 3.1 mm through the selected clear nasal passage with a spiral tracheal tube. The appropriate size of the tracheal tube for a child was determined with the following formula (10): Internal diameter (mm) = age/3 + 3.5 in both groups. The same type of tube was used in each group. Before intubation, enough lidocaine gel was placed on the tracheal tube, and the FOB was guided into patients with a suitable spiral tracheal tube. All tracheal tubes were cuffed and heat-softened in warm normal saline and lubricated to reduce mechanic stimuli to airway structures. During the intubation, the head of the patient was the in supine position, and an assistant applied a jaw thrust for opening the nasopharyngeal passage and improved the image in all patients in the FOB group. If indicated (a suboptimal laryngeal view or resistance in passing of the tracheal tube), anterior laryngeal pressure and tongue withdrawal by digital traction was performed to improve the laryngeal field of view. When the glottis was clearly visible, the FOB was advanced through the vocal cords, and jaw thrust movement was released. To prevent the stimulation of the carina, the tube was placed 4 cm below the glottis, sliding over the FOB. Intubation was verified with the FOB, and end-tidal CO2 concentrations at 35-40 mmHg were monitored. A throat pack was inserted by the anesthetist after the measurements were taken. Anesthesia was maintained with 2% sevoflurane and 50% N20 in oxygen with 1.5 l min-1 fresh gas flow and 35-40 mmHg end-tidal CO2 concentrations. Isolyte-P was administered at rate of 15 mL/kg/h IV, and acetaminophen (15 mg kg-1) was infused for postoperative analgesia in all children.
SBP and HR were recorded at baseline, after induction of anesthesia, at the time of intubation, and 1, 3 and 5 min after intubation. The intubation time (the time from when manual ventilation with a facemask stopped to restarting ventilation via the nasotracheal tube and when carbon dioxide (CO2) was detected by capnography) was recorded by another anesthetist with a digital stopwatch. Nose bleeding after intubation (epistaxis), laryngospasms, bradycardia (HR<65 beat min-1), hypoxic episodes (SpO2<90%) and the surgery type were also recorded. Adverse events (hoarseness, sore throat) were assessed 24 h after surgery. If a sore throat developed, additional analgesics were not administered. If bradycardia or desaturation (SpO2<90%) occurred for more than 2 min, the intubation was interrupted, and patients were ventilated with 100% oxygen and were administered IV atropine (5-10 µg / kg).
- Conditions
- Nasotracheal Intubation
- Being tested
- Direct laryngoscopy and fiberoptic bronchoscopy
- Keywords
- direct laryngoscopy, fiberopitc bronchoscopy, nasotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct laryngoscopy and fiberoptic bronchoscopyDevice
Also called tonopen
These devices is used in endotracheal intubation and tonopen for measuring of intraoculer pressure. I want to see whcih is better.
| Study group | Role | What they receive |
|---|---|---|
| fiberoptic bronchoscopy | Other | I want to see the difference between the two group about hemodynamic and intraoculer pressure responses about fiberoptic bronchoscopy. Receives: Device: Direct laryngoscopy and fiberoptic bronchoscopy |
| direct laryngoscopy | Other | I want to see the difference between the two group about hemodynamic and intraoculer pressure responses about direct laryngoscopy. Receives: Device: Direct laryngoscopy and fiberoptic bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured: From Begining of Anesthesia induction to 5th minutes of intubation
Heart rate
Measured: From Begining of Anesthesia induction to 5th minutes of intubation
Adverse events
Measured: within the first 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2017
- Study completion4 Apr 2017
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.
- More trials run by Inonu 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Selim Ozkan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993692
- Sponsor's protocol ID
- Asozkan
- Status last verified
- Feb 2018
- First submitted
- 1 Dec 2016
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasotracheal Intubation in Children for Outpatient Dental Surgery: Is Fiberoptic Bronchoscopy Useful?
- ClinicalTrials.gov ID
- NCT02993692
- Acronym / sponsor ID
- Asozkan
- Conditions
- Nasotracheal Intubation
- Keywords
- direct laryngoscopy, fiberopitc bronchoscopy, nasotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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.
The aim of study was to compare the hemodynamic responses and adverse events associated with nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct laryngoscope (DLS) in children undergoing general anesthesia for outpatient dental surgery. Eighty children (aged 5-15 years) were scheduled to undergo outpatient dental surgery under general anesthesia and who required nasotracheal intubation were included.
Detailed description
Investigators obtained confirmation from the Inonu University Medical Faculty Hospital Ethics Committee (2015/101) and written informed consent from the guardians of all 80 children. These children, who had a American Society of Anesthesia physical status of I-II, had a Mallampati Score of 1-2, were aged 5-15 years, were scheduled to undergo outpatient dental surgery under general anesthesia, and required nasotracheal intubation were included in this prospective and randomized study. Exclusion criteria included the following: the patient's refusal for study consent, active upper respiratory infection, airway abnormalities, nasal mass or nasal injury, bleeding disorders, allergies to anesthetics, uncontrolled hypertension, morbid obesity, hepatic or renal failure, cardiovascular diseases, a history of nasopharyngeal surgery and those who were difficult to intubate. Children were randomly assigned into the direct laryngoscopy group (n = 40) or the fiberoptic bornchoscopy group (n = 40) according to a computer-randomized table. General anesthesia was administered to children due to the learning difficulties. The number of models was decided by a statistical power analysis after the conclusions from the pretest were obtained. All children fasted at least for 6 h before surgery, and the oral intake of clear fluids was restricted for 2-3 h. Premedication of midazolam (0.5 mg/kg) was orally administered in apple juice (0.5 mL/kg of body weight) 1 h prior to anesthesia. After being admitted to the operating room, the patient's systolic blood pressure (SBP) and heart rate (HR) were continually monitored with a multichannel physiologic monitor and the baseline values for SBP and HR were recorded. Thirty min before the intubation attempt, the nasal mucosa of both nostrils were anesthetized with a topical vasoconstrictor (0.05% xylometazoline spray, and 2% lidocaine 1 mL two times in each nostril) (9) to attenuate cardiovascular responses and adverse events in all children. Anesthesia was induced with 8% sevoflurane with eight deep breaths via a face mask, and the patient was maintained on 4% end-tidal sevoflurane, fentanyl 2 µr/kg and rocuronium 0.6 mg/kg. NTI was achieved 2 min after rocuronium injection. The more patent nostril was selected for intubation. An experienced anesthetist performed all intubations in the study and an assistant applied the maneuvers (jaw trust) and evaluated the patient during the postoperative visits. All NTIs, both DLS and FOB, were conducted by the same experienced anesthetist (the anesthetist had performed DLS and the FOB nasal intubation in more than 150 patients, including in at least 100 children before the study). A study nurse documented the anesthetic data and timing. In the DLS group, the spiral tube was inserted into the nose and intubated with a Macintosh laryngoscope according to conventional procedures using Magill forceps. In the FOB group, NTI was conducted using an FOB with an outer diameter of 3.1 mm through the selected clear nasal passage with a spiral tracheal tube. The appropriate size of the tracheal tube for a child was determined with the following formula (10): Internal diameter (mm) = age/3 + 3.5 in both groups. The same type of tube was used in each group. Before intubation, enough lidocaine gel was placed on the tracheal tube, and the FOB was guided into patients with a suitable spiral tracheal tube. All tracheal tubes were cuffed and heat-softened in warm normal saline and lubricated to reduce mechanic stimuli to airway structures. During the intubation, the head of the patient was the in supine position, and an assistant applied a jaw thrust for opening the nasopharyngeal passage and improved the image in all patients in the FOB group. If indicated (a suboptimal laryngeal view or resistance in passing of the tracheal tube), anterior laryngeal pressure and tongue withdrawal by digital traction was performed to improve the laryngeal field of view. When the glottis was clearly visible, the FOB was advanced through the vocal cords, and jaw thrust movement was released. To prevent the stimulation of the carina, the tube was placed 4 cm below the glottis, sliding over the FOB. Intubation was verified with the FOB, and end-tidal CO2 concentrations at 35-40 mmHg were monitored. A throat pack was inserted by the anesthetist after the measurements were taken. Anesthesia was maintained with 2% sevoflurane and 50% N20 in oxygen with 1.5 l min-1 fresh gas flow and 35-40 mmHg end-tidal CO2 concentrations. Isolyte-P was administered at rate of 15 mL/kg/h IV, and acetaminophen (15 mg kg-1) was infused for postoperative analgesia in all children.
SBP and HR were recorded at baseline, after induction of anesthesia, at the time of intubation, and 1, 3 and 5 min after intubation. The intubation time (the time from when manual ventilation with a facemask stopped to restarting ventilation via the nasotracheal tube and when carbon dioxide (CO2) was detected by capnography) was recorded by another anesthetist with a digital stopwatch. Nose bleeding after intubation (epistaxis), laryngospasms, bradycardia (HR<65 beat min-1), hypoxic episodes (SpO2<90%) and the surgery type were also recorded. Adverse events (hoarseness, sore throat) were assessed 24 h after surgery. If a sore throat developed, additional analgesics were not administered. If bradycardia or desaturation (SpO2<90%) occurred for more than 2 min, the intubation was interrupted, and patients were ventilated with 100% oxygen and were administered IV atropine (5-10 µg / kg).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiberoptic bronchoscopy | Other | Device: Direct laryngoscopy and fiberoptic bronchoscopyI want to see the difference between the two group about hemodynamic and intraoculer pressure responses about fiberoptic bronchoscopy. |
| direct laryngoscopy | Other | Device: Direct laryngoscopy and fiberoptic bronchoscopyI want to see the difference between the two group about hemodynamic and intraoculer pressure responses about direct laryngoscopy. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA physical status of I-II, had a Mallampati Score of 1-2, were aged 5-15 years, were scheduled to undergo outpatient dental surgery under general anesthesia
Key exclusion criteria (1 listed)
- The patient's refusal for study consent, active upper respiratory infection, airway abnormalities, nasal mass or nasal injury, bleeding disorders, allergies to anesthetics, uncontrolled hypertension, morbid obesity, hepatic or renal failure, cardiovascular diseases, a history of nasopharyngeal surgery and those who were difficult to intubate.
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 |
|---|---|---|
| Direct laryngoscopy and fiberoptic bronchoscopyAlso: tonopenThese devices is used in endotracheal intubation and tonopen for measuring of intraoculer pressure. I want to see whcih is better. | Device | direct laryngoscopy, fiberoptic bronchoscopy |
Primary outcome
Systolic blood pressure
Time frame: From Begining of Anesthesia induction to 5th minutes of intubation
Heart rate
Time frame: From Begining of Anesthesia induction to 5th minutes of intubation
Adverse events
Time frame: within the first 24 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Direct laryngoscopy and fiberoptic bronchoscopy in people with Nasotracheal Intubation, run by Inonu University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: From Begining of Anesthesia induction to 5th minutes of intubation). 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?
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 23 Feb 2018.