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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lateral position group | Experimental | 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. |
|
| the supine position group | Placebo Comparator | In the control group, the patients will be placed into a supine position for extubation and observation at the end of the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lateral postion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of PRAEs | Frequency of PRAEs: Record the category and count of each PRAE occurring in each child. | during PACU |
| Number of Emergency Airway Interventions | Number of Emergency Airway Interventions: including verbal stimulation, abdominal comparession, jaw thrust, mask ventilation, rescue intubation, etc |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during PACU |
| Pain score |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Liang, PhD | Contact | 18980602201 | liangpengwch@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Peng Liang, PhD | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D016683 | Supine Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Given the intervention's nature, full blinding was impossible; only postoperative data collectors and analysts were blinded. To minimize potential bias, we plan to maintain blinding among participants, anesthesiologists and surgeons in the operating room, the data collectors who conduct inpatient and telephone follow-up visits and data analysts. However, blinding could not be preserved for investigators, post-anesthesia care unit (PACU) outcome measure recorders, care providers in the PACU.
| supine position | Procedure | The children will be changed to a supine flat-lying position for extubation. |
|
| 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. | during PACU |
| PACU stay duration | PACU stay duration: time from PACU admission until meeting PACU discharge criteria(*Aldrete score ≥9/10) | during PACU |
| Length of hospital stay | Length of hospital stay | 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. | 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. | at 7 days postoperatively |
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). |
| every 10 minutes after extubation, when leaving the PACU. |
| Emergence agitation | Emergence agitation are evaluated using the PAED scale defined as a score ≥10. | 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. | 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. | every 10 minutes after extubation, when leaving the PACU. |