- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03785977
Airway Deadspace in Children: Air-Q Versus Endotracheal Tube
A Prospective Comparison of the Airway Deadspace Associated With the Air-Q® and Endotracheal Tube Using Volumetric Capnography in Young Children
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27517
- Wake Forest Baptist Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Air-Q 5-9kg
Participants weighing 5-9kg may be chosen to wear the Air-Q device.
|
Air-Q 10-14kg
Participants weighing 10-14kg may be chosen to wear the Air-Q device.
|
Air-Q 15-20kg
Participants weighing 15-20kg may be chosen to wear the Air-Q device.
|
ETT 5-9kg
Participants weighing 5-9kg may be chosen to wear the ETT device.
|
ETT 10-14kg
Participants weighing 10-14kg may be chosen to wear the ETT device.
|
ETT 15-20kg
Participants weighing 15-20kg may be chosen to wear the ETT device.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean Value of Airway Dead Space
Tidsramme: 10 minutes
|
A mean value observed over the first 10 minutes following placement of the ETT or the AirQ at the beginning of the case will be recorded.
|
10 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Lung Compliance measured by Respironics NM3 respiratory monitors
Tidsramme: 10 minutes
|
The values of lung compliance will be collected and reported.
|
10 minutes
|
Airway Resistance measured by Respironics NM3 respiratory monitors
Tidsramme: 10 minutes
|
The value of resistance to flow in the airways will be collected and reported
|
10 minutes
|
Volume of Carbon Dioxide Associated with the Devices
Tidsramme: 10 minutes
|
The volume of carbon dioxide associated with the devices will be recorded and reported.
|
10 minutes
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB00055260
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Kliniske forsøg med Airway Deadspace
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University of MalayaUkendtGenerel anæstesi | Supraglottic Airway Device | Larynx maske Airway
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Ann & Robert H Lurie Children's Hospital of ChicagoAfsluttetSupraglottic AirwayForenede Stater
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Ajou University School of MedicineAfsluttetLarynx maske AirwayKorea, Republikken
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Universiti Kebangsaan Malaysia Medical CentreAfsluttetSupraglottic Airway DeviceMalaysia
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Virginia Commonwealth UniversityAfsluttetTonsillektomi | Larynx maske AirwayForenede Stater
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The University of Texas Health Science Center,...AfsluttetEndotracheal intubation | Supraglottic AirwayForenede Stater
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The University of Texas Health Science Center,...AfsluttetEndotracheal intubation | Supraglottic AirwayForenede Stater
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University of British ColumbiaAfsluttet
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The University of Texas Health Science Center,...Ambu A/SAfsluttetSupraglottic AirwayForenede Stater
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Cancer Institute and Hospital, Chinese Academy...Ukendt