Lateral Positioning for Extubation After Adenotonsillectomy

NCT ID: NCT07108218

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-08-27

Brief 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. 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.

Conditions

Perioperative Respiratory Adverse Events; Adenoidectomy; Tonsillectomy; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

lateral position group

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.

Group Type: EXPERIMENTAL

lateral postion

Intervention Type: 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.

the supine position group

In the control group, the patients will be placed into a supine position for extubation and observation at the end of the procedure.

Group Type: PLACEBO_COMPARATOR

supine position

Intervention Type: PROCEDURE

The children will be changed to a supine flat-lying position for extubation.

Interventions

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.

Intervention Type: PROCEDURE

supine position

The children will be changed to a supine flat-lying position for extubation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Subjects aged 1-6 years old without gender limit.

2. Scheduled for an ambulatory adenotonsillectomy under general anesthesia.

3. American Society of Anesthesiologists (ASA) classification grade I or II.

4. Informed consent obtained from the patients' parents or legal guardians, who have expressed willingness to cooperate.

Exclusion Criteria

1. Presence of concomitant cardiac or pulmonary dysfunction or other significant systemic comorbidities.

2. History of difficult airway management or congenital/acquired structural anomalies of the airway.

3. Active respiratory tract infection within 30 days preceding surgery.

4. Preoperative neurological disorders or developmental abnormalities.

5. Intraoperative occurrence of major complications necessitating deviation from the planned anesthesia protocol or surgical procedure.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Peng Liang，MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peng Liang, PhD

Role: STUDY_DIRECTOR

West China Hospital

Locations

West China Hospital

Chengdu, Sichuan, China

Countries

China

Central Contacts

Peng Liang, PhD

Role: CONTACT

liangpengwch@scu.edu.cn

18980602201

Facility Contacts

Peng Liang, PhD

Role: primary

liangpengwch@scu.edu.cn

18980602201

Other Identifiers

2025HX880

Identifier Type: -

Identifier Source: org_study_id