Prospective Evaluation of Routine Extubation Criteria in Children with Upper Respiratory Symptoms Undergoing Elective Surgery

Citation:

Templeton TW, Smith LD, Mosher T, Saha AK, Hodges AS, Vishneski SR, et al. A Prospective Evaluation of Routine Extubation Criteria in Children with Upper Respiratory Symptoms Undergoing Elective Surgery. Anesthesiology. 2026. doi:10.1097/ALN.0000000000006197

This episode asks whether routine awake-extubation readiness criteria remain reassuring in children with upper respiratory infection symptoms undergoing elective surgery. The primary comparison is very uncertain: observed success was 94.7% without symptoms versus 93.9% with symptoms. Symptomatic children may have more desaturation, and unadjusted confounding limits causal conclusions.

Study at a glance

- Design and setting: Prospective observational cohort at a single center in the United States, conducted between November 20, 2019 and June 24, 2025, in elective outpatient or day-hospital pediatric surgery with planned general endotracheal anesthesia and awake extubation. Registered at ClinicalTrials.gov as NCT04155892 and prepared using Strengthening the Reporting of Observational Studies in Epidemiology guidelines.

- Population: 927 subjects were screened; 799 were enrolled and extubated with one or more of the five extubation criteria; 756 patients were analyzed in the primary cohorts, including 379 in the non-upper respiratory infection symptom group and 377 in the upper respiratory infection symptom group. Inclusion criteria were children aged ≤9 years presenting for elective outpatient or day-hospital surgery with anticipated discharge on the day of surgery or postoperative day 1 and planned general endotracheal anesthesia; primary analysis required at least 3 of the Big Five extubation criteria. Female sex was 31.1%; age was 31.0 ± 26.4 months in the non-upper respiratory infection group and 37.9 ± 25.0 months in the upper respiratory infection group.

- Exposure and comparator: Primary exposure was preoperative upper respiratory infection symptom status based on a parent or caregiver questionnaire: scores ≥3 defined the upper respiratory infection symptom group; scores 0 or 1 defined the non-upper respiratory infection reference group; score 2 was excluded as indeterminate. The questionnaire gave one point for each positive response plus a parent or caregiver sickness assessment scored 0 to 3; in the upper respiratory infection group, the median survey score was 4 (IQR 3 to 6). At emergence and extubation, an independent observer recorded the Big Five criteria: tidal volume >5 mL/kg, conjugate gaze, facial grimace, purposeful movement, and eye opening.

- Primary outcome: Successful awake extubation at extubation occurred in 359/379 patients in the non-upper respiratory infection group, 94.7% (95% CI 92.5% to 97.0%), versus 354/377 patients in the upper respiratory infection group, 93.9% (95% CI 91.5% to 96.3%). Adjusted effect estimate not reported; unadjusted risk difference for non-upper respiratory infection versus upper respiratory infection was 0.8% (95% CI -2.6% to 4.2%); p-value not reported. The observed estimate fell within the study’s 5% clinical equivalence margin, but causal equivalence is very uncertain (very low certainty).

- Key secondary outcome: At least one peri-extubation desaturation event occurred in 103/377 patients in the upper respiratory infection group, 27.3% (95% CI 22.8% to 31.8%), versus 62/379 in the non-upper respiratory infection group, 16.4% (95% CI 12.6% to 20.1%). Adjusted effect estimate not reported; unadjusted risk difference was 10.9% (95% CI 5.1% to 16.0%); p-value not reported, so upper respiratory infection symptoms may be associated with more desaturation (low certainty). Other secondary contrasts included visible endotracheal tube secretions, risk difference 43.3% (95% CI 37.1% to 49.5%, low certainty); major intervention, risk difference 1.0% (95% CI -1.1% to 3.2%, very low certainty); laryngospasm, risk difference 0.0% (95% CI -1.5% to 1.5%, very low certainty); postdischarge respiratory healthcare, risk difference 1.6% (95% CI -0.2% to 3.4%, very low certainty); and postanesthesia care unit oxygen saturation nadir, 96% (IQR 94 to 98) versus 95% (IQR 92 to 97), p-value <0.001 (very low certainty).

- Confounding: No multivariable regression, propensity score, g-method, instrumental-variable, or other formal confounding adjustment was reported; group contrasts were unadjusted. Baseline prognostic factors differed between groups, including age, American Society of Anesthesiologists physical status, sleep-disordered breathing, and surgery type, and clinician experience was not accounted for. Clinicians were not blinded to questionnaire score, and albuterol administration differed as printed: 5/377 (1.3%) in the non-upper respiratory infection group versus 31/379 (8.2%) in the upper respiratory infection group, with printed denominators differing from final cohort sizes.

- Risk of bias and certainty: ROBINS-E overall risk of bias was Serious. The main concern was serious confounding; moderate concerns included selection of participants, exposure classification, deviations from intended exposure, missing data, and selection of reported results, while outcome measurement was Low primarily for standardized observer-graded peri-extubation outcomes. Overall certainty was very low for successful awake extubation, low for peri-extubation desaturation and visible secretions, and very low for most other outcomes.