Health TrialsbyHealthPanel

Airway US in Predicting Difficult Pediatric Laryngoscopy

ConditionAirway Complication of Anesthesia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-6
SponsorAssiut University

About this trial

The hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Secondary objectives will include establishing, if possible, a cut-off point in these measurements; to compare these measures against the classic pre-intubation clinical screening tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gender both males and females

ASA Class I and II

Age 2 years to 6

Children scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.

Disqualifiers

Congenital upper airway malformation,

Head and neck swellings,

Scars,

Radiation to the neck,

Trial population

Children aged 2-6 years, ASA I, II who will be scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SonoSite™ S Series ultrasound

    Device

    US measurements will be performed in the pre-operating room a , patients are placed in supine position with the head in a sniffing position on a surgical pillow and using the 15 MHz linear array transducer of the SonoSite™ S Series ultrasound in transverse position. A scan is made from the skin surface of the floor of the mouth to the trachea exerting the minimum possible pressure to identify the structures correctly.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

prediction of a Difficult laryngoscopy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords).

To evaluate the accuracy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Namely the DSH, DSE, DSG, DSH+DSE, and DSH-DSE in prediction of difficult laryngoscopy.

Time frame
Preoperative

Secondary outcomes

1

The Modified Mallampati Score (MMS).

The Modified Mallampati Score (MMS): * Class I: Soft palate, uvula, fauces, pillars visible. * Class II: Soft palate, major part of uvula, fauces visible. * Class III: Soft palate, base of uvula visible. * Class IV: Only hard palate visible.

Time frame
At Intubation
2

The thyromental distance (TMD)

The thyromental distance (TMD) is the distance from the chin (mentum) to the top of the notch of the thyroid cartilage with the head fully extended measured by a ruler.

Time frame
preoperative
3

The upper lip bite test (ULBT)

The upper lip bite test (ULBT) performed by an anesthesiologist associated with this research and a specialist with more than 10 years of experience and in charge of the operating room.

Time frame
Preoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: