Airway DeadspaceNCT03785977
Airway Deadspace in Children: Air-Q Versus Endotracheal Tube
An observational study of Airway Deadspace, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Deadspace
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 9 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: To perform this investigation we 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 5 years of age (roughly 5-20 kg).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27517
About this study
Official title: A Prospective Comparison of the Airway Deadspace Associated With the Air-Q® and Endotracheal Tube Using Volumetric Capnography in Young Children
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.
Read the detailed description
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
- Airway Deadspace
- Keywords
- Ventilation, pediatrics, airway management, respiration
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Value of Airway Dead Space
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.
Measured: 10 minutes
Secondary outcomes (3)
Lung Compliance measured by Respironics NM3 respiratory monitors
The values of lung compliance will be collected and reported.
Measured: 10 minutes
Airway Resistance measured by Respironics NM3 respiratory monitors
The value of resistance to flow in the airways will be collected and reported
Measured: 10 minutes
Volume of Carbon Dioxide Associated with the Devices
The volume of carbon dioxide associated with the devices will be recorded and reported.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start25 Mar 2019
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Airway DeadspaceStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Templeton, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785977
- Sponsor's protocol ID
- IRB00055260
- Status last verified
- Mar 2020
- First submitted
- 19 Dec 2018
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19454544Templeton 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.
PubMed 27871584Garcia-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.
PubMed 18042854Drake-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.
PubMed 28108038Casati 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.
PubMed 9873966Templeton 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.
PubMed 29878544Templeton 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.
PubMed 27687391Al-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.
PubMed 30133920Ream 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.
PubMed 7832337
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of the Airway Deadspace Associated With the Air-Q® and Endotracheal Tube Using Volumetric Capnography in Young Children
- ClinicalTrials.gov ID
- NCT03785977
- Acronym / sponsor ID
- IRB00055260
- Conditions
- Airway Deadspace
- Keywords
- Ventilation, pediatrics, airway management, respiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- To perform this investigation we 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 5 years of age (roughly 5-20 kg).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Value of Airway Dead Space
Time frame: 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.
3 secondary outcomes
Lung Compliance measured by Respironics NM3 respiratory monitors
Time frame: 10 minutes
Airway Resistance measured by Respironics NM3 respiratory monitors
Time frame: 10 minutes
Volume of Carbon Dioxide Associated with the Devices
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Background: PubMed 19454544Micaglio 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.
- Background: PubMed 27871584Templeton 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.
- Background: PubMed 18042854Garcia-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.
- Background: PubMed 28108038Drake-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.
- Background: PubMed 9873966Casati 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.
- Background: PubMed 29878544Templeton 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.
- Background: PubMed 27687391Templeton 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.
- Background: PubMed 30133920Al-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.
- Background: PubMed 7832337Ream 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Templeton, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Deadspace, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Value of Airway Dead Space (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785977, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.