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

NCT ID: NCT06000267

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2023-10-31

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).

Detailed Description

Participants will be divided into groups: up to 1 yrs of age, 1-2.9 yrs, 3-4.9, 5-6.9, and 7 yrs and older.

The investigators will test predictive value, sensitivity and specificity of anthropometric parameters used for airway assessment in pediatric patients, as well as gender, age, BMI, ASA score.

Anatomical parameters that will be measured the day before surgery: chin, inter - incisor gap, hyomental distance (HMD), hyoid - thyroid distance (HT), neck circumference, neck length, neck extension, lower lip to chin distance (LCD), tragus to chin distance (TMA), thyromental distance (TMD), sternomental distance (SMD).

Mallampati test will be performed in children older than 5 years and best oropharyngeal view (BOV) will be determined for younger children. Colorado Pediatric Airway Score (COPUR) will be calculated.

All patients will be premedicated with midazolam 0.5 mg/kg orally, 30 minutes before intervention or 0.1 mg/kg iv. Anesthesia induction will be intravenous: thiopentone 5 mg/kg or propofol 2.5 mg/kg, fentanyl 3 mcg/kg and non depolarizing muscle relaxant rocuronium 1 mg/kg or cis-atracurium 0.15 mg/kg. Face mask ventilation will be quantified as grade 0-4. Anesthesia maintenance will be intravenous or inhalatory depending on anesthesiologists decision. Patients will be intubated with Macintosh blade in the supine position, without additional elevation of occipital part of the head. Difficult laryngoscopy is defined as CL grade III and IV and they predict difficult endotracheal intubation. Intubation difficulty score will be used to asses intubation. Intubation difficulty will be defined by IDS - intubation difficulty score > 5.

Standard procedures will be performed in case of difficult mask ventilation and intubation.

Conditions

Difficult Airway

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Intubation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Childrens Hospital Belgrade

OTHER

Sponsor Role: lead

Responsible Party

Ivana Petrov Bojicic

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivana Petrov, MD

Role: PRINCIPAL_INVESTIGATOR

University children hospital

Locations

University Children hospital

Belgrade, , Serbia

Site Status: RECRUITING

Countries

Serbia

Central Contacts

Ivana Petrov, MD

Role: CONTACT

kikapetrov75@gmail.com

64 152 5959 ext. +381

Facility Contacts

Ivana Petrov, MD

Role: primary

kikapetrov75@gmail.com

641525959 ext. +381

Other Identifiers

UCHBelgrade

Identifier Type: -

Identifier Source: org_study_id