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Not yet recruiting NCT07108218

Lateral Positioning for Extubation After Adenotonsillectomy

No phase Interventional Perioperative Respiratory Adverse Events Adenoidectomy Tonsillectomy Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lateral postion, supine position.
Who it may be relevant to
Registry conditions: Perioperative Respiratory Adverse Events, Adenoidectomy, Tonsillectomy, Children. Basic parameters: 1 year — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
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Official title

Lateral Positioning During the Anesthesia Emergence After Ambulatory Adenotonsillectomy in Children on Postoperative Respiratory Adverse Events: a Multi-center Randomized Controlled Trial

Overview

The postoperative recovery period following general anesthesia has been associated with a 30%-50% incidence of postoperative respiratory adverse events (PRAEs) in pediatric populations, including laryngospasm, airway obstruction, and hypoxemia. Despite the limited effects of existing pharmacological and operative interventions, positional optimization (e.g., lateral or semirecumbent position) may play a potential role by decreasing airway resistance and improving oxygenation. However, evidence-based evidence for its use in pediatric populations is still lacking, necessitating the urgent need for randomized controlled trials.

Detailed description

This study is a multi-center, prospective, RCT conducted at four tertiary hospitals in China. It will be planned to include 350 subjects who meet the inclusion criteria and will be randomly divided into the lateral position and supine position group in a 1:1 ratio by the method of block group randomization stratified by centers. In the supine position group, the children will be extubated at the end of the procedure and observed in the decubitus position until the patient's Aldrete score was \>9 and they left the PACU, whereas in the lateral position group, the children will be extubated and observed in the head-up 30° lateral position. The primary outcome is the incidence of PRAEs. Secondary outcomes included frequency of PRAE, number of airway devices used during the postoperative recovery period, time to tracheal extubation, length of stay in the recovery room, and incidence of PRAE at 24 hours and 7 days. postoperatively. Safety outcomes include the incidence of peripheral IV access dislodgement, monitoring device detachment rate, and patient falls rate. Exploratory outcomes comprise pain levels (assessed via the FLACC scale), agitation scores (PAED scale), sedation scores (Ramsay scale), and PONV scores, all evaluated at postoperative extubation and PACU discharge.

Interventions

  • Procedure lateral postion
    The children will be positioned on their sides with their heads elevated by 30°, a thin pillow behind their backs, the upper legs bent, and the lower legs straightened.
  • Procedure supine position
    The children will be changed to a supine flat-lying position for extubation.

Primary outcome measures

  • the occurrence of postoperative respiratory adverse events (PRAEs) [Time frame: during PACU]
Secondary outcome measures (7)
  • Frequency of PRAEs [Time frame: during PACU]
  • Number of Emergency Airway Interventions [Time frame: during PACU]
  • Tracheal extubation time [Time frame: during PACU]
  • PACU stay duration [Time frame: during PACU]
  • Length of hospital stay [Time frame: postoperative day 1]
  • The PRAEs at 24 hours after surgery [Time frame: at 24 hours postoperatively]
  • The PRAEs at 7 days after surgery [Time frame: at 7 days postoperatively]

Eligibility criteria

Inclusion criteria

  • Subjects aged 1-6 years old without gender limit.
  • Scheduled for an ambulatory adenotonsillectomy under general anesthesia.
  • American Society of Anesthesiologists (ASA) classification grade I or II.
  • Informed consent obtained from the patients' parents or legal guardians, who have expressed willingness to cooperate.

Exclusion criteria

  • Presence of concomitant cardiac or pulmonary dysfunction or other significant systemic comorbidities.
  • History of difficult airway management or congenital/acquired structural anomalies of the airway.
  • Active respiratory tract infection within 30 days preceding surgery.
  • Preoperative neurological disorders or developmental abnormalities.
  • Intraoperative occurrence of major complications necessitating deviation from the planned anesthesia protocol or surgical procedure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • West China Hospital — Chengdu

Identifiers

NCT: NCT07108218 · 2025HX880

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗