Upper Respiratory Tract InfectionsNCT04155892
Evaluation of Extubation Criteria in Children With Upper Respiratory Infection (URI)
An observational study of Upper Respiratory Tract Infections, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- How many people
- 760 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2019to 3 Jul 2025
- 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 Up to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: * All study participants must be < 8 years of age and undergoing general anesthesia and surgery with an endotracheal tube * The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1. * The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.
Who may be able to join
- All study participants must be undergoing general anesthesia and surgery with an endotracheal tube
- The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an endotracheal tube (ETT) for their surgical procedure who are to be discharged same day or on postoperative day 1.
- The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.
Who cannot join
- History of home oxygen use or ventilator dependence,
- Patients undergoing emergent procedures.
- Patients with cyanotic congenital heart disease.
- Patients receiving a surgical procedure where the duration of post procedure
- admission is anticipated to be greater or equal to 2 postoperative days.
- Patients undergoing anesthesia for imaging procedures alone.
Show all 9Show fewer
- Patients who are extubated deep intentionally.
- Patients intended to be managed with supraglottic airway.
- Patients undergoing total IV anaesthesia (TIVA).
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Prospective Observational Study Evaluating Extubation Criteria in Children Less Than 8 Years of Age With Upper Respiratory Infection Undergoing Outpatient or Day Hospital Based Surgery
The investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.
Read the detailed description
The objectives of this study are to evaluate various extubation criteria and their predictive value for successful extubation in non-cardiac surgical procedures. To evaluate the predictive value of room air oxygen and an original preoperative URI questionnaire in pediatric patients with URI or URI symptoms.
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- Extubation criteria, Pediatric Anesthesia, Outpatient surgery
- Medical subject headings
- Respiratory Tract Infections
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 |
|---|---|---|
| URI group | This group includes participants <8 years of age undergoing elective procedures with a score of at least 3 on our pre-operative URI survey. | |
| non-URI group | This group includes participants <8 years of age undergoing elective procedures with no URI symptoms or recent URI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful extubation in children with at least 3 of the five criteria present
The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume > 5 cc/kg)
Measured: Day 1
Rate of participants with an extubation requiring intervention
The quality of extubation will be graded as successful, intervention required or major intervention required
Measured: Day 1
Rate of participants with an extubation requiring major intervention
The quality of extubation will be graded as successful, intervention required or major intervention required
Measured: Day 1
Rate of participants with a successful extubation
The quality of extubation will be graded as successful, intervention required or major intervention required
Measured: Day 1
Secondary outcomes (4)
Rate of on time and anticipated discharge from the hospital
Measured: Up to 5 days after discharge
Rate of patients seeking additional care following discharge for respiratory related symptoms
Measured: Up to 5 days after discharge
Preoperative room air oxygen saturation
Measured: Day 1
Rate of extubation success per the number of factors present at time of extubation
Rate of success at the presence of 3 to 6 predictors (eye opening, facial grimace, purposeful movement, conjugate gaze, tidal volume > 5 cc/kg, and ETCO2<56 mmHg) at time of extubation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start4 Dec 2019
- Primary completion30 Jun 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 760 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
- NCT04155892
- Sponsor's protocol ID
- IRB00056059
- Status last verified
- Oct 2025
- First submitted
- 5 Nov 2019
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Templeton TW, Smith LD, Mosher T, Saha AK, Hodges AS, Vishneski SR, Pecorella SH, Tran LCB, Hammon DE, Smith TE, Ririe DG, Downard MG, Lee LK, McPherson PJ, McLaughlin CS, Sutton CJ, Bradshaw JD, Tennant PR, Templeton LB. A Prospective Evaluation of Routine Extubation Criteria in Children with Upper Respiratory Symptoms Undergoing Elective Surgery. Anesthesiology. 2026 Nov 1;145(5):1097-1106. doi: 10.1097/ALN.0000000000006197. Epub 2026 Jun 8.
PubMed 42257685
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Evaluating Extubation Criteria in Children Less Than 8 Years of Age With Upper Respiratory Infection Undergoing Outpatient or Day Hospital Based Surgery
- ClinicalTrials.gov ID
- NCT04155892
- Acronym / sponsor ID
- IRB00056059
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- Extubation criteria, Pediatric Anesthesia, Outpatient surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 7 Nov 2019 (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 investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.
Detailed description
The objectives of this study are to evaluate various extubation criteria and their predictive value for successful extubation in non-cardiac surgical procedures. To evaluate the predictive value of room air oxygen and an original preoperative URI questionnaire in pediatric patients with URI or URI symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| URI group | – | –This group includes participants <8 years of age undergoing elective procedures with a score of at least 3 on our pre-operative URI survey. |
| non-URI group | – | –This group includes participants <8 years of age undergoing elective procedures with no URI symptoms or recent URI. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * All study participants must be < 8 years of age and undergoing general anesthesia and surgery with an endotracheal tube * The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1. * The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.
Key inclusion criteria (3 listed)
- All study participants must be undergoing general anesthesia and surgery with an endotracheal tube
- The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an endotracheal tube (ETT) for their surgical procedure who are to be discharged same day or on postoperative day 1.
- The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.
Key exclusion criteria (9 listed)
- History of home oxygen use or ventilator dependence,
- Patients undergoing emergent procedures.
- Patients with cyanotic congenital heart disease.
- Patients receiving a surgical procedure where the duration of post procedure
- admission is anticipated to be greater or equal to 2 postoperative days.
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
The rate of successful extubation in children with at least 3 of the five criteria present
Time frame: Day 1
The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume > 5 cc/kg)
Rate of participants with an extubation requiring intervention
Time frame: Day 1
The quality of extubation will be graded as successful, intervention required or major intervention required
Rate of participants with an extubation requiring major intervention
Time frame: Day 1
The quality of extubation will be graded as successful, intervention required or major intervention required
Rate of participants with a successful extubation
Time frame: Day 1
The quality of extubation will be graded as successful, intervention required or major intervention required
4 secondary outcomes
Rate of on time and anticipated discharge from the hospital
Time frame: Up to 5 days after discharge
Rate of patients seeking additional care following discharge for respiratory related symptoms
Time frame: Up to 5 days after discharge
Preoperative room air oxygen saturation
Time frame: Day 1
Rate of extubation success per the number of factors present at time of extubation
Time frame: Day 1
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 16 Jan 2026.
- Derived from this study: PubMed 42257685Templeton TW, Smith LD, Mosher T, Saha AK, Hodges AS, Vishneski SR, Pecorella SH, Tran LCB, Hammon DE, Smith TE, Ririe DG, Downard MG, Lee LK, McPherson PJ, McLaughlin CS, Sutton CJ, Bradshaw JD, Tennant PR, Templeton LB. A Prospective Evaluation of Routine Extubation Criteria in Children with Upper Respiratory Symptoms Undergoing Elective Surgery. Anesthesiology. 2026 Nov 1;145(5):1097-1106. doi: 10.1097/ALN.0000000000006197. Epub 2026 Jun 8.
- Individual participant dataSharing planned: No
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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 Upper Respiratory Tract Infections, 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 3 inclusion and 9 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 16 Jan 2026. 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?
The rate of successful extubation in children with at least 3 of the five criteria present (time frame: Day 1). The study lists 4 primary outcomes in all. 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 NCT04155892, which also lists 1 linked publication.
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 16 Jan 2026.