Perioperative Respiratory Adverse EventsNCT07108218
Lateral Positioning for Extubation After Adenotonsillectomy
A study testing lateral postion and supine position in people with Perioperative Respiratory Adverse Events and Adenoidectomy, run by Sichuan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Perioperative Respiratory Adverse Events, Adenoidectomy, Tonsillectomy
- What is being tested?
- lateral postion and supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2025to 27 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital
Chengdu, Sichuan, 610041
Peng Liang, PhD, 18980602201, liangpengwch@scu.edu.cn
About this study
Official title: Lateral Positioning During the Anesthesia Emergence After Ambulatory Adenotonsillectomy in Children on Postoperative Respiratory Adverse Events: a Multi-center Randomized Controlled Trial
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.
Read the 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.
- Being tested
- lateral postion, supine position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral postionProcedure or surgery
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.
supine positionProcedure or surgery
The children will be changed to a supine flat-lying position for extubation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: lateral postion |
| 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. Receives: Procedure: supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during PACU
Secondary outcomes (7)
Frequency of PRAEs
Frequency of PRAEs: Record the category and count of each PRAE occurring in each child.
Measured: during PACU
Number of Emergency Airway Interventions
Number of Emergency Airway Interventions: including verbal stimulation, abdominal comparession, jaw thrust, mask ventilation, rescue intubation, etc
Measured: 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.
Measured: during PACU
PACU stay duration
PACU stay duration: time from PACU admission until meeting PACU discharge criteria(*Aldrete score ≥9/10)
Measured: during PACU
Length of hospital stay
Length of hospital stay
Measured: 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.
Measured: 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.
Measured: at 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion27 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Respiratory Adverse EventsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Liang，MD, Sichuan University
- Investigators
- Peng Liang, PhD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108218
- Sponsor's protocol ID
- 2025HX880
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Positioning During the Anesthesia Emergence After Ambulatory Adenotonsillectomy in Children on Postoperative Respiratory Adverse Events: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07108218
- Acronym / sponsor ID
- 2025HX880
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 27 Aug 2026 (estimated)
- First posted
- 6 Aug 2025 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral position group | Experimental | Procedure: lateral postionIn 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 | Procedure: supine positionIn the control group, the patients will be placed into a supine position for extubation and observation at the end of the procedure. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lateral postionThe 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 or surgery | lateral position group |
| supine positionThe children will be changed to a supine flat-lying position for extubation. | Procedure or surgery | the supine position group |
Primary outcome
the occurrence of postoperative respiratory adverse events (PRAEs)
Time frame: during PACU
PRAEs include a diverse array of respiratory complications, including laryngospasm, bronchospasm, apnea, airway obstruction, stridor, cough/choking, hypoxemia.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Perioperative Respiratory Adverse Events
Not yet recruitingObservational study
PRAE and Asymptomatic and Symptomatic URI Patients
Upper Respiratory Infection, Pediatric Surgical Patients
Active, not recruitingObservational study
Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy
Heart Rate Monitoring, Vagal Bradycardia
Not yet recruitingObservational study
Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring
Cleft Palate, Cleft Lip
Recruiting
Teleconsultation vs Face-to-Face Evaluation for Perioperative Respiratory Events in Pediatric Adenotonsillectomy
Adenotonsillar Hypertrophy
Recruiting
Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on on Perioperative Sedation Related Adverse Events in Elderly ERCP Patients
Biliary and Pancreatic Diseases, Endoscopic Retrograde Cholangiopancreatography (ERCP)
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.
Peng Liang, PhD study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral postion and supine position in people with Perioperative Respiratory Adverse Events and Adenoidectomy, run by Sichuan University at 1 site in China.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Aug 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Liang, PhD (18980602201, liangpengwch@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of postoperative respiratory adverse events (PRAEs) (time frame: during PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2025.