Incidence and Contributing Anthropometric Factors of Difficult Airway in Pediatric Surgical Patients

NCT06000267 | Unknown

• 1 other identifier: UCHBelgrade
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, observational study is to identify predictors of difficult mask ventilation, direct laryngoscopy and intubation in pediatric patients scheduled for elective surgery and to determine their incidence. As a final goal, the investigators will try to define new scoring system for difficult airway prediction. Participants will be pediatric patients age infant till school age. Participants will have their airway assessed one day before surgery by taking anthropometric measurements of face and neck. After iv anesthesia induction and application of muscle relaxant, the investigators will assess difficulty of face mask ventilation by using grading from 0-4. Direct laryngoscopy will be performed with Macintosh blade and experienced anesthesiologist will determine Cormack - Lehane score as well as intubation difficulty score (IDS).

Conditions

Difficult Airway

Keywords

children; intubation; face mask ventilation; best oropharyngeal view

Outcome Measures

Primary Outcomes (1)

• incidence of difficult mask ventilation and intubation

  Determination of grade 3 and 4 of mask ventilation incidence in different age groups of children and incidence of difficult intubation defined as intubation difficultly score \>5

  one year

Secondary Outcomes (1)

• Identification of anthropometric parameters of face and neck which determine difficult airway in children

  one year

Interventions

Intubation PROCEDURE

All the patients will be ventilated with face mask and intubated before elective surgery

Eligibility Criteria

• Age: 28 Days - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patient will be divided in 5 groups according to age: infants, children from 1 - 2,9 years, 3 - 4,9 years, 5 - 6,9 years and older than 7 years.

You may qualify if:

• Pediatric patients from one month to 14 years old scheduled for elective surgery in general endotracheal anesthesia.

You may not qualify if:

• Congenital syndromes which include difficult airway (Pierre Robin, Goldenhar syndrome, Treacher Collins syn, Down syn, Edwards, Arthrogryposis, Apart syn etc.), craniofacial dysmorphia, ENT, maxillofacial and cardiac surgery patients, patients with resent respiratory infections

Sponsors & Collaborators

• University Childrens Hospital Belgrade: lead

Study Sites (1)

University Children hospital

Belgrade, 11000, Serbia

RECRUITING

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Ivana Petrov, MD

  University children hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivana Petrov, MD

CONTACT

64 152 5959; kikapetrov75@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: January 10, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)