High-flow Nasal Oxygenation for Open Mouth
Primary Purpose
Anesthesia, General, Apnea
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Apnea with high-flow nasal cannula
Apnea
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia, General focused on measuring High-flow nasal cannula, Preoxygenation, Apnea time, General anesthesia
Eligibility Criteria
Inclusion Criteria:
- Children younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2.
Exclusion Criteria:
- Refusal to enrollment from one or more of legal guardians of the patient
- Children who are planned to use supraglottic airway device
- Children with upper respiratory tract infection or pulmonary interstitial disease
- Preterm babies under 40 weeks of postconceptual age
- Children who are expected to have difficult airway for bag-mask ventilation
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High flow
Control
Arm Description
Apply high-flow nasal oxygenation during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired.
Apply nothing during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired.
Outcomes
Primary Outcome Measures
Apnea time
Time required for pulse oximetry to drop to 92% after start of apnea
Secondary Outcome Measures
End-tidal carbon dioxide
End-tidal carbon dioxide partial pressure during anesthesia
Pulse oximetry
Pulse oximetry during anesthesia
Non-invasive blood pressure
Non-invasive blood pressure measured from forearm or leg
Oxygen reserve index
Oxygen reserve index measured from finger or toe
Time to 100%
Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea
Minimum value of pulse oximetry
Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea
1st value of end-tidal carbon dioxide
First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea
Full Information
NCT ID
NCT04290728
First Posted
February 24, 2020
Last Updated
March 26, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04290728
Brief Title
High-flow Nasal Oxygenation for Open Mouth
Official Title
Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Change in the study plan
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to evaluate the effect of high-flow nasal oxygenation on safe apnea time for children undergoing general anesthesia, with their mouth open.
Detailed Description
Oxygenation via high-flow nasal cannula is gaining popularity in various clinical settings. It is known to increase apnea time for apneic patients including children. However, high-flow nasal cannula is known to be ineffective when the patient's mouth is kept open.
When trying to intubate the patient during induction of anesthesia, the patient should be apneic with administration of neuromuscular blocking agent, and the mouth should be open for introduction of laryngoscope.
We designed a prospective randomized controlled study to evaluate the effect of high-flow nasal oxygenation in the aforementioned setting for trying to intubate the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, General, Apnea
Keywords
High-flow nasal cannula, Preoxygenation, Apnea time, General anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High flow
Arm Type
Experimental
Arm Description
Apply high-flow nasal oxygenation during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Apply nothing during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired.
Intervention Type
Device
Intervention Name(s)
Apnea with high-flow nasal cannula
Other Intervention Name(s)
Airvo 2
Intervention Description
Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min
Intervention Type
Other
Intervention Name(s)
Apnea
Intervention Description
Apnea without any application of oxygenation
Primary Outcome Measure Information:
Title
Apnea time
Description
Time required for pulse oximetry to drop to 92% after start of apnea
Time Frame
Elapsed time starting from discontinuation of oxygen to the time point that pulse oximetry first reaches 92% (not to exceed 520 seconds)
Secondary Outcome Measure Information:
Title
End-tidal carbon dioxide
Description
End-tidal carbon dioxide partial pressure during anesthesia
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
Pulse oximetry
Description
Pulse oximetry during anesthesia
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
Non-invasive blood pressure
Description
Non-invasive blood pressure measured from forearm or leg
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
Oxygen reserve index
Description
Oxygen reserve index measured from finger or toe
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
Time to 100%
Description
Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea
Time Frame
Elapsed time starting from re-start of bag-mask ventilation at the end of apnea period to the time point that pulse oximetry first reaches 100% (estimated less than 2 minutes)
Title
Minimum value of pulse oximetry
Description
Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
1st value of end-tidal carbon dioxide
Description
First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea
Time Frame
At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2.
Exclusion Criteria:
Refusal to enrollment from one or more of legal guardians of the patient
Children who are planned to use supraglottic airway device
Children with upper respiratory tract infection or pulmonary interstitial disease
Preterm babies under 40 weeks of postconceptual age
Children who are expected to have difficult airway for bag-mask ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26705976
Citation
Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
Results Reference
background
PubMed Identifier
8827740
Citation
Frei FJ, Ummenhofer W. Difficult intubation in paediatrics. Paediatr Anaesth. 1996;6(4):251-63. doi: 10.1111/j.1460-9592.1996.tb00447.x. No abstract available.
Results Reference
background
PubMed Identifier
12412683
Citation
Schibler A, Hall GL, Businger F, Reinmann B, Wildhaber JH, Cernelc M, Frey U. Measurement of lung volume and ventilation distribution with an ultrasonic flow meter in healthy infants. Eur Respir J. 2002 Oct;20(4):912-8. doi: 10.1183/09031936.02.00226002.
Results Reference
background
PubMed Identifier
15449573
Citation
King W, Petrillo T, Pettignano R. Enteral nutrition and cardiovascular medications in the pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2004 Sep-Oct;28(5):334-8. doi: 10.1177/0148607104028005334.
Results Reference
background
PubMed Identifier
19672959
Citation
Schibler A, Yuill M, Parsley C, Pham T, Gilshenan K, Dakin C. Regional ventilation distribution in non-sedated spontaneously breathing newborns and adults is not different. Pediatr Pulmonol. 2009 Sep;44(9):851-8. doi: 10.1002/ppul.21000.
Results Reference
background
PubMed Identifier
12780980
Citation
Schibler A, Henning R. Positive end-expiratory pressure and ventilation inhomogeneity in mechanically ventilated children. Pediatr Crit Care Med. 2002 Apr;3(2):124-128. doi: 10.1097/00130478-200204000-00006.
Results Reference
background
PubMed Identifier
9356095
Citation
Erb T, Marsch SC, Hampl KF, Frei FJ. Teaching the use of fiberoptic intubation for children older than two years of age. Anesth Analg. 1997 Nov;85(5):1037-41. doi: 10.1097/00000539-199711000-00013.
Results Reference
background
PubMed Identifier
28035669
Citation
Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
Results Reference
background
PubMed Identifier
29330853
Citation
Lodenius A, Piehl J, Ostlund A, Ullman J, Jonsson Fagerlund M. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) vs. facemask breathing pre-oxygenation for rapid sequence induction in adults: a prospective randomised non-blinded clinical trial. Anaesthesia. 2018 May;73(5):564-571. doi: 10.1111/anae.14215. Epub 2018 Jan 13.
Results Reference
background
PubMed Identifier
28100527
Citation
Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401.
Results Reference
background
PubMed Identifier
30784037
Citation
Lyons C, Callaghan M. Uses and mechanisms of apnoeic oxygenation: a narrative review. Anaesthesia. 2019 Apr;74(4):497-507. doi: 10.1111/anae.14565. Epub 2019 Feb 19.
Results Reference
background
PubMed Identifier
15871753
Citation
Wettstein RB, Shelledy DC, Peters JI. Delivered oxygen concentrations using low-flow and high-flow nasal cannulas. Respir Care. 2005 May;50(5):604-9.
Results Reference
background
PubMed Identifier
19846404
Citation
Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
Results Reference
background
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High-flow Nasal Oxygenation for Open Mouth
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