An interventional study of lateral postion and supine position in Perioperative Respiratory Adverse Events, Adenoidectomy and Tonsillectomy, sponsored by Sichuan University. Not yet recruiting at 1 site in China. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Sichuan University · Not applicable, Interventional, and Prevention
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.
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.
Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
In the experimental group, the children will be placed in a head-up 30° lateral position for tracheal extubation and observation at the end of the procedure.
Procedure: lateral postion
In the control group, the patients will be placed into a supine position for extubation and observation at the end of the procedure.
Procedure: supine position
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.
The children will be changed to a supine flat-lying position for extubation.
the occurrence of postoperative respiratory adverse events (PRAEs)
PRAEs include a diverse array of respiratory complications, including laryngospasm, bronchospasm, apnea, airway obstruction, stridor, cough/choking, hypoxemia.
Time frame: during PACU
Frequency of PRAEs
Frequency of PRAEs: Record the category and count of each PRAE occurring in each child.
Time frame: during PACU
Number of Emergency Airway Interventions
Number of Emergency Airway Interventions: including verbal stimulation, abdominal comparession, jaw thrust, mask ventilation, rescue intubation, etc
Time frame: during PACU
Tracheal extubation time
Tracheal extubation time: From the time the patient is transferred to the PACU until the intubation is removed. Extubation criteria: spontaneous breathing recovery and spontaneous eye opening.
Time frame: during PACU
PACU stay duration
PACU stay duration: time from PACU admission until meeting PACU discharge criteria(\*Aldrete score ≥9/10)
Time frame: during PACU
Length of hospital stay
Length of hospital stay
Time frame: postoperative day 1
The PRAEs at 24 hours after surgery
The PRAEs at 24 hours after surgery include laryngospasm, bronchospasm, airway obstruction, stridor, cough/choking, hypoxemia, upper respiratory tract infection and pulmonary infection.
Time frame: at 24 hours postoperatively
The PRAEs at 7 days after surgery
The PRAEs at 7 days postoperatively include laryngospasm, bronchospasm, airway obstruction, stridor, cough/choking, hypoxemia, upper respiratory tract infection and pulmonary infection.
Time frame: at 7 days postoperatively
Adverse events
Adverse events include the incidence of peripheral intravenous access dislodgment, monitoring device detachment rate, and the rate of bed falls. Other adverse events including hypertension, hypotension, tachycardia, bradycardia, arrhythmias are also recorded.
Time frame: during PACU
Pain score
Pain levels are evaluated using the FLACC scale. The scale has 5 categories (face, legs, activity, cry, consolability). Each category is scored on the 0-2 scale, which results in a total score of 0-10 (0=relaxed and comfortable; 1-3=mild discomfort; 4-6 = moderate pain; 7-10 = sever discomfort or pain or both).
Time frame: every 10 minutes after extubation, when leaving the PACU.
Emergence agitation
Emergence agitation are evaluated using the PAED scale defined as a score ≥10.
Time frame: every 10 minutes after extubation, when leaving the PACU.
Sedation scores
Sedation scores are evaluated using the Ramsay scale. The Ramsay sedation score with scores of 1(irritability), 2(consciousness and cooperative), 3(deeper sleep and more agile response), 4(lighter sleep with faster awakening time), 5(sound sleep with slow response), and 6(no response) points, respectively.
Time frame: every 10 minutes after extubation, when leaving the PACU.
Postoperative nausea and vomiting (PONV)
The assessment of postoperative nausea and vomiting (PONV) involves observing and inquiring about the presence of nausea, vomiting, or retching in the child.
Time frame: every 10 minutes after extubation, when leaving the PACU.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sichuan University