Airway Complication of AnesthesiaLaryngoscopyNCT04677894
Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery
An observational study of Airway Complication of Anesthesia and Peroperative Complication, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Background and Objective: Airway control is a condition that should be evaluated primarily in anesthesia practice in the pediatric age group. Failed intubation or prolonged intubation duration can cause atelectasis and hypoxia in children. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Airway Complication of Anesthesia, Peroperative Complication, Intraoperative Hypertension
- What is being tested?
- Laryngoscopy
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Jun 2020
- How long will I take part?
- 7 Months
- Phase
- Observational
- 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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: The study included 66 ASA I-II patients with an age range of 4-13 years and who were scheduled for elective dental surgery under general anesthesia with intubation.
Who may be able to join
- Healthy children between the ages of 4-13
- Ordu University School of Medicine ,pediatric age group ,elective oral surgery 4-13 years and who were scheduled for elective oral surgery under general anesthesia with intubation If Patients with a Cormack -Lehane score 1,2 or 3 and if Mallampathy score of 1,2 or 3 were inccluded from the study
Who cannot join
- With malignancy disease patients
- with norological disorders
- with congenital heart disease
- with airway abnormality
- with airway disease patients
- Patients age Under 4 years , Above 13 years
- If Patients with a Cormack -Lehane score 4 and if Mallampathy score of 4 were excluded from the study -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ordu University School of Medicine ,Department of Anesthesiology and Reanimation
Ordu, 52200
About this study
Official title: Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery: a Randomized Clinical Trial
Background and Objective: Airway control is a condition that should be evaluated primarily in anesthesia practice in the pediatric age group. Failed intubation or prolonged intubation duration can cause atelectasis and hypoxia in children. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia.
Methods: Sixty-six patients were divided into two groups according to the procedure used during intubation, namely, direct laryngoscopy or video laryngoscopy. The Cormack-Lehane and Mallampati scores, intubation duration, heart rate at minutes 0, 1, 3 and 5 during intubation, mean arterial pressure, EtCO2and SpO2 values were recorded for all the patients.
Read the detailed description
Many techniques in the management of a difficult airway have been used in adult patients. In pediatric patients, awake fiberoptic intubation is difficult or even impossible . The video laryngoscope is a new tool produced by combining video technology and laryngoscope. Published studies on the video laryngoscope were mostly performed in adults . In this study, we used a Macintosh laryngoscope, which is a routinely used tool in anesthesiology, and a McGrath video laryngoscope, which is a type of a newly developed video laryngoscope that has not widely been used in the pediatric age group. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia. We also evaluated whether Macintosh laryngoscopy and McGrath videolaryngoscopy improved the stress response and whether these approaches facilitated the intubation procedure.
- Conditions
- Airway Complication of Anesthesia, Peroperative Complication, Intraoperative Hypertension, Tachycardia, Sinus, Desaturation of Blood
- Being tested
- Laryngoscopy
- Keywords
- pediatric oral surgery, direct laryngoscopy, video laryngoscopy, nasotracheal intubation
- Medical subject headings
- Intraoperative Complications, Tachycardia, Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaryngoscopyDevice
During the intubation, the head of the patient was kept in a neutral position, patients were nasotracheally intubated
| Study group | Role | What they receive |
|---|---|---|
| Group Direct Laringoscopy | Group DL: Group of patients intubated using a Macintoch blade laryngoscope. Receives: Device: Laryngoscopy | |
| Group Videolaringoscopy | Group VL: Group of patients intubated using a McGrath video laryngoscope. Receives: Device: Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart Rate (HR)
Measured: During surgery 0. minute
Heart Rate
Heart Rate (HR)
Measured: During surgery 1. minute
Heart Rate
Heart Rate (HR)
Measured: During surgery 3. minute
Heart Rate
Heart Rate (HR)
Measured: During surgery 5. minute
Heart Rate
Heart Rate (HR)
Measured: During surgery 10. minute
Mean Arterial Pressure
Mean Arterial Pressure (MAP)
Measured: During surgery 0. minute
Mean Arterial Pressure
Mean Arterial Pressure (MAP)
Measured: During surgery 1. minute
Mean Arterial Pressure
Mean Arterial Pressure (MAP)
Measured: During surgery 3. minute
Mean Arterial Pressure
Mean Arterial Pressure (MAP)
Measured: During surgery 5. minute
Mean Arterial Pressure
Mean Arterial Pressure (MAP)
Measured: During surgery 10. minute
Saturation
SpO2
Measured: During surgery 0. minute
Saturation
SpO2
Measured: During surgery 1. minute
Saturation
SpO2
Measured: During surgery 3. minute
Saturation
SpO2
Measured: During surgery 5. minute
Saturation
SpO2
Measured: During surgery 10. minute
End Tidal Carbondioxide
EtCO2
Measured: During surgery 0. minute
End Tidal Carbondioxide
EtCO2
Measured: During surgery 1. minute
End Tidal Carbondioxide
EtCO2
Measured: During surgery 3. minute
End Tidal Carbondioxide
EtCO2
Measured: During surgery 5. minute
End Tidal Carbondioxide
EtCO2
Measured: During surgery 10. minute
Secondary outcomes (3)
Entubation Time
Entubation time , (minute)
Measured: During Surgery 1.minute
Entubation Time
Entubation time , (minute)
Measured: During Surgery 2.minute
Entubation Time
Entubation time , (minute)
Measured: During Surgery 3.minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Canakci, Ordu University
- Investigators
- Ebru Canakci, MD, Principal investigator, Ordu University School of Medicine Department of Anesthesiology and ReanimationAhmet Gultekin, MD, Study chair, Namık Kemal University School of Medicine Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677894
- Sponsor's protocol ID
- ECanakci
- Acronym
- Laryngoscopy
- Status last verified
- Dec 2020
- First submitted
- 29 Nov 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video Laryngoscopy and Direct Laryngoscopy for Nasotracheal Intubation During Pediatric Dental Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04677894
- Acronym / sponsor ID
- Laryngoscopy / ECanakci
- Conditions
- Airway Complication of Anesthesia, Peroperative Complication, Intraoperative Hypertension, Tachycardia, Sinus, Desaturation of Blood
- Keywords
- pediatric oral surgery, direct laryngoscopy, video laryngoscopy, nasotracheal intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 21 Dec 2020 (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.
Background and Objective: Airway control is a condition that should be evaluated primarily in anesthesia practice in the pediatric age group. Failed intubation or prolonged intubation duration can cause atelectasis and hypoxia in children. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia.
Methods: Sixty-six patients were divided into two groups according to the procedure used during intubation, namely, direct laryngoscopy or video laryngoscopy. The Cormack-Lehane and Mallampati scores, intubation duration, heart rate at minutes 0, 1, 3 and 5 during intubation, mean arterial pressure, EtCO2and SpO2 values were recorded for all the patients.
Detailed description
Many techniques in the management of a difficult airway have been used in adult patients. In pediatric patients, awake fiberoptic intubation is difficult or even impossible . The video laryngoscope is a new tool produced by combining video technology and laryngoscope. Published studies on the video laryngoscope were mostly performed in adults . In this study, we used a Macintosh laryngoscope, which is a routinely used tool in anesthesiology, and a McGrath video laryngoscope, which is a type of a newly developed video laryngoscope that has not widely been used in the pediatric age group. The aim of this study was to examine the effects of Macintosh laryngoscopy and McGrath videolaryngoscopy on hemodynamic parameters in pediatric patients who were scheduled to undergo elective dental surgery and required intubation for the application of general anesthesia. We also evaluated whether Macintosh laryngoscopy and McGrath videolaryngoscopy improved the stress response and whether these approaches facilitated the intubation procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Direct Laringoscopy | – | Device: LaryngoscopyGroup DL: Group of patients intubated using a Macintoch blade laryngoscope. |
| Group Videolaringoscopy | – | Device: LaryngoscopyGroup VL: Group of patients intubated using a McGrath video laryngoscope. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study included 66 ASA I-II patients with an age range of 4-13 years and who were scheduled for elective dental surgery under general anesthesia with intubation.
Key inclusion criteria (2 listed)
- Healthy children between the ages of 4-13
- Ordu University School of Medicine ,pediatric age group ,elective oral surgery 4-13 years and who were scheduled for elective oral surgery under general anesthesia with intubation If Patients with a Cormack -Lehane score 1,2 or 3 and if Mallampathy score of 1,2 or 3 were inccluded from the study
Key exclusion criteria (7 listed)
- With malignancy disease patients
- with norological disorders
- with congenital heart disease
- with airway abnormality
- with airway disease patients
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 |
|---|---|---|
| LaryngoscopyDuring the intubation, the head of the patient was kept in a neutral position, patients were nasotracheally intubated | Device | Group Direct Laringoscopy, Group Videolaringoscopy |
Primary outcome
Heart Rate
Time frame: During surgery 0. minute
Heart Rate (HR)
Heart Rate
Time frame: During surgery 1. minute
Heart Rate (HR)
Heart Rate
Time frame: During surgery 3. minute
Heart Rate (HR)
Heart Rate
Time frame: During surgery 5. minute
Heart Rate (HR)
Heart Rate
Time frame: During surgery 10. minute
Heart Rate (HR)
Mean Arterial Pressure
Time frame: During surgery 0. minute
Mean Arterial Pressure (MAP)
Mean Arterial Pressure
Time frame: During surgery 1. minute
Mean Arterial Pressure (MAP)
Mean Arterial Pressure
Time frame: During surgery 3. minute
Mean Arterial Pressure (MAP)
Mean Arterial Pressure
Time frame: During surgery 5. minute
Mean Arterial Pressure (MAP)
Mean Arterial Pressure
Time frame: During surgery 10. minute
Mean Arterial Pressure (MAP)
Saturation
Time frame: During surgery 0. minute
SpO2
Saturation
Time frame: During surgery 1. minute
SpO2
Saturation
Time frame: During surgery 3. minute
SpO2
Saturation
Time frame: During surgery 5. minute
SpO2
Saturation
Time frame: During surgery 10. minute
SpO2
End Tidal Carbondioxide
Time frame: During surgery 0. minute
EtCO2
End Tidal Carbondioxide
Time frame: During surgery 1. minute
EtCO2
End Tidal Carbondioxide
Time frame: During surgery 3. minute
EtCO2
End Tidal Carbondioxide
Time frame: During surgery 5. minute
EtCO2
End Tidal Carbondioxide
Time frame: During surgery 10. minute
EtCO2
3 secondary outcomes
Entubation Time
Time frame: During Surgery 1.minute
Entubation Time
Time frame: During Surgery 2.minute
Entubation Time
Time frame: During Surgery 3.minute
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 21 Dec 2020.
- 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.
Ebru Canakci, MD principal investigator
Ordu University School of Medicine Department of Anesthesiology and Reanimation
Ahmet Gultekin, MD study chair
Namık Kemal University School of Medicine Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia and Peroperative Complication, run by Ordu University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 21 Dec 2020. 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 Turkey (Türkiye). 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?
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?
Heart Rate (time frame: During surgery 0. minute). The study lists 20 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 21 Dec 2020.