Difficult Bag Mask Ventilation and Difficult Intubation in Children

NCT02823392 | Completed DMC

• 2 other identifiers: DBMV765DI51
• Study Type: observational
• Target: 765
• Locations: 1 country
• Sites: 1

Brief Summary

Unanticipated difficult airway comprises of unexpected difficult bag mask ventilation or unforeseen difficult laryngoscopy. The incidence of difficult laryngoscopy or unanticipated difficult intubation in children was varied from 1.2 %to 4.77% depending on general or specific population and type of surgery. The known risk factors of difficult intubation in children were young age, associated syndrome or congenital abnormality and obstructive sleep apnea. Moreover, the predictors of difficult laryngoscopy by physical examination were associated with short interincisors distance, high frontal plane to chin distance, short thyromental distance and Cormack \& Lehane classification 3 or 4. However, little knowledge is known regarding difficult bag mask ventilation in children. The incidence of difficult bag mask ventilation was 6.6% according to the single study. A few study reported the independent risk factor of difficult bag mask ventilation in children which were young age, obesity, use of neuromuscular blocking agent and airway surgery. In addition, the association between difficult bag mask ventilation and difficult intubation are still unknown. To understand more of difficult bag mask ventilation in children and factor-association may reduce incidence of morbidity and mortality by identifying difficult airway, preparing personnel and equipment tool in order to improve clinical outcome in pediatric anesthesia. The objectives of the study were to determine the predictors of difficult bag mask ventilation and the association with unexpected difficult intubation in children who came for elective surgery in tertiary care hospital of southern Thailand.

Conditions

Inadequate or Impaired Breathing Pattern or Ventilation; Difficult Intubation; Anesthesia; Adverse Effect

Keywords

unexpected difficult bag mask ventilation; difficult intubation; predictors; pediatric anesthesia

Outcome Measures

Primary Outcomes (1)

• Difficult bag mask ventilation

  the occurrence of at least two following events which were requiring application of CPAP with opening airway maneuvers, requiring oropharyngeal airway, requiring two-person bag mask ventilation, unable to perform bag mask ventilation or presence of desaturation (SpO2 \< 95%).

  4 years

Secondary Outcomes (2)

• difficult laryngoscopy

  4 years

• difficult intubation

  4 years

Interventions

DBMV OTHER

the occurrence of at least two following events which were requiring application of CPAP with opening airway maneuvers, requiring oropharyngeal airway, requiring two-person bag mask ventilation, unable to perform bag mask ventilation or presence of desaturation (SpO2 \< 95%).

Eligibility Criteria

• Age: 1 Day - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

We recruited children aged up to 9 years, ASA physical status of 1-3, who came for general anesthesia with oroendotracheal tube intubation (OETT) for elective surgery at Songklanajarind Hospital

You may qualify if:

• aged up to 9 years
• ASA physical status of 1-3
• came for general anesthesia with oroendotracheal tube intubation
• elective surgery

You may not qualify if:

• had difficult airway or having airway anomaly or syndrome related difficult airway
• presence of active pulmonary disease
• had preoperative oxygen saturation at room air \< 95%

Sponsors & Collaborators

• Prince of Songkla University: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• maliwan s oofuvong, MD, PhD

  Faculty Of Medicine, Prince Of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Maliwan Oofuvong

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 6, 2016
• Study Start: September 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)