Airway Deadspace in Children: Air-Q Versus Endotracheal Tube

NCT ID: NCT03785977

Last Updated: 2020-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-25

Study Completion Date

2019-08-09

Brief Summary

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The objective of this study will be to measure the airway deadspace associated with use of appropriately sized an AirQ, a commonly used supraglottic airway in young children weighing between 5 and 20 kg and compare that to the airway deadspace associated with use of an endotracheal tube (ETT) in similarly sized children undergoing controlled ventilation.

Detailed Description

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There is an increasing interest in the use of supraglottic airway devices in progressively younger and younger patients. One issue that has not been well evaluated is the contribution of these devices to airway dead space in young children and infants. Volumetric capnography is the only non-invasive technology available at the current time to evaluate airway deadspace. Volumetric capnography essentially monitors the flow of CO2 over time and from the expired waveform one can determine different respiratory parameters including dead space. This is clinically important in young children as the clinician begins to evaluate whether or not to use an endotracheal tube or supraglottic airway in these patients. To perform this investigation the study team will use volumetric capnography to examine the airway dead space associated with these devices during and elective general surgery and urologic procedures in healthy children between the ages of 0 and 6 years of age (roughly 5-20 kg).

Participants in the study will be given ETT or Air-Q as an intervention, but the investigator does not assign specific interventions to the study participants.

Conditions

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Airway Deadspace

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Air-Q 5-9kg

Participants weighing 5-9kg may be chosen to wear the Air-Q device.

No interventions assigned to this group

Air-Q 10-14kg

Participants weighing 10-14kg may be chosen to wear the Air-Q device.

No interventions assigned to this group

Air-Q 15-20kg

Participants weighing 15-20kg may be chosen to wear the Air-Q device.

No interventions assigned to this group

ETT 5-9kg

Participants weighing 5-9kg may be chosen to wear the ETT device.

No interventions assigned to this group

ETT 10-14kg

Participants weighing 10-14kg may be chosen to wear the ETT device.

No interventions assigned to this group

ETT 15-20kg

Participants weighing 15-20kg may be chosen to wear the ETT device.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 3 months and 6 years of age weighing between 5 and 20 kg
* Patient presenting outpatient urologic or general surgery

Exclusion Criteria

* History of difficult airway/intubation
* Patients suspected to have a difficult airway.
* Morbid obesity BMI \>39
* Emergency status of surgery
* Patients exposed to second hand smoke
* Patients with Asthma
* Patients with a URI symptom such as nasal drainage, cough, or fever within 7 days of the date of surgery
* History of Prematurity
Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Templeton, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Micaglio M, Bonato R, De Nardin M, Parotto M, Trevisanuto D, Zanardo V, Doglioni N, Ori C. Prospective, randomized comparison of ProSeal and Classic laryngeal mask airways in anaesthetized neonates and infants. Br J Anaesth. 2009 Aug;103(2):263-7. doi: 10.1093/bja/aep106. Epub 2009 May 19.

Reference Type BACKGROUND
PMID: 19454544 (View on PubMed)

Templeton TW, Hoke LK, Templeton LB, Ririe DG, Rose DM, Bryan YF. A comparison of 3 ventilation strategies in children younger than 1 year using a Proseal laryngeal mask airway: a randomized controlled trial. J Clin Anesth. 2016 Dec;35:502-508. doi: 10.1016/j.jclinane.2016.07.042. Epub 2016 Oct 19.

Reference Type BACKGROUND
PMID: 27871584 (View on PubMed)

Garcia-Fernandez J, Tusman G, Suarez-Sipmann F, Llorens J, Soro M, Belda JF. Programming pressure support ventilation in pediatric patients in ambulatory surgery with a laryngeal mask airway. Anesth Analg. 2007 Dec;105(6):1585-91, table of contents. doi: 10.1213/01.ane.0000287674.64086.f1.

Reference Type BACKGROUND
PMID: 18042854 (View on PubMed)

Drake-Brockman TF, Ramgolam A, Zhang G, Hall GL, von Ungern-Sternberg BS. The effect of endotracheal tubes versus laryngeal mask airways on perioperative respiratory adverse events in infants: a randomised controlled trial. Lancet. 2017 Feb 18;389(10070):701-708. doi: 10.1016/S0140-6736(16)31719-6. Epub 2017 Jan 18.

Reference Type BACKGROUND
PMID: 28108038 (View on PubMed)

Casati A, Fanelli G, Torri G. Physiological dead space/tidal volume ratio during face mask, laryngeal mask, and cuffed oropharyngeal airway spontaneous ventilation. J Clin Anesth. 1998 Dec;10(8):652-5. doi: 10.1016/s0952-8180(98)00108-1.

Reference Type BACKGROUND
PMID: 9873966 (View on PubMed)

Templeton TW, Goenaga-Diaz EJ, Templeton LB, Ririe DG. An in vitro analysis of the dead space in 5 supraglottic airway devices intended for use in small children and infants. Paediatr Anaesth. 2018 Jun;28(6):570-572. doi: 10.1111/pan.13382. No abstract available.

Reference Type BACKGROUND
PMID: 29878544 (View on PubMed)

Templeton TW, Hoke LK, Yaung J, Aschenbrenner CA, Rose DM, Templeton LB, Bryan YF. Comparing 3 ventilation modalities by measuring several respiratory parameters using the ProSeal laryngeal mask airway in children. J Clin Anesth. 2016 Nov;34:272-8. doi: 10.1016/j.jclinane.2016.04.031. Epub 2016 May 15.

Reference Type BACKGROUND
PMID: 27687391 (View on PubMed)

Al-Subu A, Jooste E, Hornik CP, Fleming GA, Cheifetz IM, Ofori-Amanfo G. Correlation between minute carbon dioxide elimination and pulmonary blood flow in single-ventricle patients after stage 1 palliation and 2-ventricle patients with intracardiac shunts: A pilot study. Paediatr Anaesth. 2018 Jul;28(7):618-624. doi: 10.1111/pan.13423.

Reference Type BACKGROUND
PMID: 30133920 (View on PubMed)

Ream RS, Schreiner MS, Neff JD, McRae KM, Jawad AF, Scherer PW, Neufeld GR. Volumetric capnography in children. Influence of growth on the alveolar plateau slope. Anesthesiology. 1995 Jan;82(1):64-73. doi: 10.1097/00000542-199501000-00010.

Reference Type BACKGROUND
PMID: 7832337 (View on PubMed)

Other Identifiers

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IRB00055260

Identifier Type: -

Identifier Source: org_study_id

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