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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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).

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 groups in NCT02993692
Study groupRoleWhat they receive
fiberoptic bronchoscopyOtherI 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 laryngoscopyOtherI 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.

  1. Systolic blood pressure

    Measured: From Begining of Anesthesia induction to 5th minutes of intubation

  2. Heart rate

    Measured: From Begining of Anesthesia induction to 5th minutes of intubation

  3. 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.

  1. First posted15 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionJan 2017
  4. Study completion4 Apr 2017

Resources

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)
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

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.

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