Difficult Intubation Clinical Trial
Official title:
Difficult Bag Mask Ventilation and Unanticipated Difficult Intubation in Children: A Prospective Cohort Study
NCT number | NCT02823392 |
Other study ID # | DBMV765 |
Secondary ID | DI51 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2008 |
Est. completion date | December 2012 |
Verified date | October 2019 |
Source | Prince of Songkla University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 765 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 9 Years |
Eligibility |
Inclusion Criteria: - aged up to 9 years - ASA physical status of 1-3 - came for general anesthesia with oroendotracheal tube intubation - elective surgery Exclusion Criteria: - 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% |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine, Prince of Songkla University | Hat Yai | Songkhla |
Lead Sponsor | Collaborator |
---|---|
Prince of Songkla University | McGill University Health Centre/Research Institute of the McGill University Health Centre |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | difficult laryngoscopy | laryngoscopic view 3 or 4 | 4 years | |
Secondary | difficult intubation | The occurrence of at least two of the following: 1) at least three intubation attempts using a conventional laryngoscope blade, either Miller or Macintosh [5]; 2) intubation time (the summation of all attempts from applying a laryngoscope to the endotracheal tube that passed the vocal cords) >300 seconds; and 3) the occurrence of desaturation (SpO2 <95%) | 4 years |
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