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Anesthesia Intubation ComplicationNCT03676387

Prediction of Optimal Pediatric Endotracheal Tube Size "Aged Based Formula Versus Ultrasonography"

A study testing ultrasound guided in people with Anesthesia Intubation Complication, run by Mansoura 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

Background: Ultrasound (US) imaging technique has recently emerged as a novel, simple, portable, noninvasive tool helpful for airway assessment and management. Initial few published reports were on soft tissue imaging of neck, focusing on pre-tracheal structure and anterior tracheal wall. Read more about this study

Who is it for?
Ages 1 year to 6 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia Intubation Complication
What is being tested?
ultrasound guided
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
1 Apr 2016to 16 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 1 year to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • fifty four children aged from 1 to 6 years of either sex
  • scheduled for elective surgery not exceeded 90 minutes
  • underwent general anesthesia with uncuffed endotracheal tube.

Who cannot join

  • an anticipated difficult airway
  • any respiratory disease that might cause airway narrowing
  • pre-exiting laryngeal or tracheal pathology
  • any lesion that could cause airway deformity due to fibrosis or the presence of a neck anatomical pathologies that might have unpredictable effect on the ultrasound assessment of the airway
  • prolonged surgery more than 90 minutes .

About this study

Background: Ultrasound (US) imaging technique has recently emerged as a novel, simple, portable, noninvasive tool helpful for airway assessment and management. Initial few published reports were on soft tissue imaging of neck, focusing on pre-tracheal structure and anterior tracheal wall. In our study, we compared the measurement of subglottic diameter using ultrasonography and the aged based formula in prediction of endotracheal tube size in children underwent elective surgical operation under general anesthesia.

Methods: Patients were randomly divided in 2 groups (27 patients each) using a computer-generated randomization schedule. The first group was aged based group (group AB) (n = 27): the endotracheal tube size was determined according to age of the child [inner diameter [ID] in mm = (age in yr/4) +4. The second group was ultrasound based group (group UB) (n = 27): the endotracheal tube size was determined according to the subglottic transverse diameter that was estimated with ultrasonography (the outer diameter of endotracheal tube (ETT OD) = 0.55*(subglottic diameter)+1.16) .

Read the detailed description

Introduction:

Pediatric tracheal intubation requires considerable expertise and can represent a challenge to many anesthesiologists(Marciniak et al.,2009). Anatomically; the larynx of a pediatric patient assumes a funnel shape with its narrowest part at the level of the cricoid ring, which cannot be seen during conventional laryngoscopy (Karsli et al.,2002).

Choosing the correct endotracheal tube (ETT) size needed for intubation of pediatric patients is important because an inappropriately too large tracheal tube can cause upper airway damage (e.g., local ischemia, ulceration, scar formation) and the potential for subsequent subglottic stenosis. In contrast, an ETT that is too small may result in insufficient ventilation, poor reliability of end-tidal gas monitoring, leakage of anesthetic gases into the operating room environment, and an enhanced risk of aspiration(Karsli et al.,2002).

Different algorithms and formula have been proposed to choose the best-fitting size of the endotracheal tube. Age-based formulas, such as those of Cole and Motoyama, have been used to estimate optimal ETT size for more than half a century (Motoyama,1990) and this formula is [inner diameter (ID) in mm = (age in yr/4) +4]. Predictive formulas for appropriate ETT size have also been based on patient weight and height as[ID in mm = 2 + height in cm/30] and [ID in mm = 2.44 + age in yr ×0.1 + height in cm ×0.02 + weight in kg ×0.016] and other formula as the width of the 5th fingernail is used for ID prediction of the ETT [ID in mm = maximum width of the 5th fingernail] (Shibasaki et al.,2010). However, these methods are not always suitable because the size of the airway varies considerably between patients.

Ultrasound guided is helpful for evaluate the subglottic transverse diameter which is safe , sample, painless and non invasive modality for prediction of proper endotracheal tube size (Jagadish G Sutagatti et al., 2017).

In this study, we compared the measurement of subglottic diameter using ultrasonography and the aged based formula in prediction of endotracheal tube size in children underwent elective surgical operation under general anesthesia.

Patients and methods:

Study design and participants After getting approval from the institutional research board(MS/16.01.143), faculty of medicine , Mansoura University, written informed consents were obtained from parents of fifty children aged from 1 to 6 years of either sex scheduled for elective surgery not exceeded 90 minutes underwent general anesthesia with uncuffed endotracheal tube. This randomized controlled study was conducted in Emergency Hospital, Mansoura University between April/2016 to April/2017 .

Patient exclusion criteria include: an anticipated difficult airway, any respiratory disease that might cause airway narrowing, pre-exiting laryngeal or tracheal pathology, any lesion that could cause airway deformity due to fibrosis or the presence of a neck anatomical pathologies that might have unpredictable effect on the ultrasound assessment of the airway and prolonged surgery more than 90 minutes .

Sample size calculation:

The appropriateness of ETT size was adopted as a primary parameter for effective size used for sample size calculation. A power of 80% was accepted with alpha error of 0.05. fifty four patients in both groups were found to be enough to detect a 20% difference between groups.

Patients were randomly divided in 2 groups (27 patients each) using a computer-generated randomization schedule.

Aged based group (group AB) (n = 27): ETT size was determined according to age of the child, inner diameter [ID] in mm = (age in yr/4) +4(Van den Berg and Mphanza, 1997).

Ultrasound based group (group UB) (n = 27): ETT was determined according to the subglottic transverse diameter that was estimated with ultrasonography.

Technique:

On arrival to the operating room, basic monitors were applied {ECG, pulse oximetry, non-invasive blood pressure (NIBP)}, baseline values were recorded and An intravenous cannula (24G) was inserted and secured . General anesthesia was induced by inhalation of sevoflurane. Muscular relaxation was achieved with atracurium (0.5mg/kg) to facilitate the endotracheal intubation under direct laryngoscopy. The patients were ventilated with sevoflurane in 100% oxygen via a facemask before intubation for 3 min for proper muscles relaxation. ETT was chosen according to each group. Aged based formula (inner diameter [ID] in mm = (age in yr/4) +4) was used in group AB and in group UB, during mask ventilation ultrasound guided subglottic transverse diameter was measured with assistant anesthesiologist help. To avoid observer bias by anesthesiologist who performs the leak test by the absence of ultrasound machine in the operating room, the ultrasound assessment also was done in group AB(aged-based).

Ultrasonography technique:

The subglottic diameter was estimated with B-mode ultrasonography (Korean, Siemens, Acuson, x300) with a 10-13-MHz linear probe positioned on the midline of the anterior neck (figure1). The evaluation began by identifying the true vocal folds as paired hyperechoic linear structures that moved with respiration and swallowing before patients were paralyzed. The probe was then moved caudally to visualize the cricoid arch which appears as an arched, rounded and hypoechoic structure (figure2). The transverse air-column diameter was measured at the lower edge of the cricoid cartilage after patients were paralyzed (figure3).

The measurements of the subglottic diameter was used to select the outer diameter of endotracheal tube by the equation [ETT OD=0.55*(subglottic diameter)+1.16] (Shibasaki et al., 2010), since the outer diameter of endotracheal tube differs among different manufactures, we used uncuffed Mallinckrodt tracheal tube with a Murphy's eyes.

The inner diameter of endotracheal tube that was calculated according to table (1) which show the correlation between outer and inner diameter of the endotracheal tube.

Determination of appropriateness of ETT size:

Another anesthesiologist who was blinded to the group allocation did the air leak test in all patients. The air leak test was done after successful intubation of ETT chosen on the basis of either of two methods, The correct tracheal tube size was considered optimal when an audible air leak around the tube at an inspiratory airway pressure was detected between 10-30 cm H2O, with the head and neck in a neutral position. The presence of an air leak was assessed by closing off the pop-off valve and allowing pressure to rise slowly until an audible leak was heard using a stethoscope on the tube. If there was no audible leak when the lung were inflated to a pressure of 30 cm H2O, the tube was exchanged with one that was 0.5 mm smaller. But if a leak occurred at an inflation pressure of less than 10 cm of H2O, the ETT was exchanged for one with the 0.5 mm larger tube.

The following parameters were monitored:

  1. Primary outcome: Number of optimum tube selection was monitored in both group (group AB and group UB).2- Number of reintubation due to large or small tube.
  2. Secondary outcome: 1- Time of intubation. 2- Complication after extubation.

Statistical analysis:

All statistical analyses were performed using SPSS for windows version 20.0 (SPSS, Chicago, IL). Continuous data we re-expressed in mean ±standard deviation (SD) white categorical data were expressed in number and percentage. The differences between two groups were determined using Student's t test for variables with continuous data and chi-square test for variables with categorical data. The 95% confidence interval (CI) for the frequency of correct size of the endotracheal tube (ETT) was calculated. Statistical significance was set at p<0.05.

Being tested
ultrasound guided
Keywords
pediatric, endotracheal tube, ultrasonography

What participants receive

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

  • ultrasound guidedOther

    Ultrasonography technique:

    The subglottic diameter was estimated with B-mode ultrasonography (Korean, Siemens, Acuson, x300) with a 10-13-MHz linear probe positioned on the midline of the anterior neck (figure1). The evaluation began by identifying the true vocal folds as paired hyperechoic linear structures that moved with respiration and swallowing before patients were paralyzed. The probe was then moved caudally to visualize the cricoid arch which appears as an arched, rounded and hypoechoic structure (figure2). The transverse air-column diameter was measured at the lower edge of the cricoid cartilage after patients were paralyzed (figure3).

    The measurements of the subglottic diameter was used to select the outer diameter of endotracheal tube by the equation [ETT OD=0.55*(subglottic diameter)+1.16] (Shibasaki et al., 2010), since the outer diameter of endotracheal tube differs among different manufactures, we used uncuffed Mallinckrodt tracheal tube with a Murphy's eyes.

Study groups in NCT03676387
Study groupRoleWhat they receive
Aged based group (group AB) (n = 27)No interventionETT size was determined according to age
Ultrasound based group (group UB) (n = 27): ETT was determinedActive comparatorETT was determined according to the subglottic transverse diameter that was estimated with ultrasonography.
Receives: Other: ultrasound guided

What is being measured

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

  1. 1- Number of optimum tube selection was monitored in both group (group AB and group UB) (number and percentage %).

    Measured: 1 year

  2. Number of reintubation due to large or small tube (number and percentage %).

    Measured: 1 year

Secondary outcomes (2)
  1. Time of intubation (minutes).

    Measured: 1 year

  2. complication after extubation

    Measured: 1 year

Timeline

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

  1. First posted18 Sep 2018
  2. Study start1 Apr 2016
  3. Primary completion16 Apr 2017
  4. Study completion16 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03676387
Sponsor's protocol ID
MansouraU1
Status last verified
Sep 2018
First submitted
11 Sep 2018
Last updated
18 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ultrasound guided in people with Anesthesia Intubation Complication, run by Mansoura 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 3 inclusion and 5 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 18 Sep 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?

1- Number of optimum tube selection was monitored in both group (group AB and group UB) (number and percentage %). (time frame: 1 year). 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 18 Sep 2018.

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