Lateral Positioning for Extubation After Adenotonsillectomy

NCT07108218 | Not Yet Recruiting DMC

• 1 other identifier: 2025HX880
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Respiratory Adverse Events; Adenoidectomy; Tonsillectomy; Children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Frequency of PRAEs

  during PACU

• Number of Emergency Airway Interventions

  during PACU

• Tracheal extubation time

  during PACU

• PACU stay duration

  during PACU

• Length of hospital stay

  postoperative day 1

Other Outcomes (5)

• Adverse events

  during PACU

• Pain score

  every 10 minutes after extubation, when leaving the PACU.

• Emergence agitation

  every 10 minutes after extubation, when leaving the PACU.

Study Arms (2)

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.

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.

Procedure: supine position

Interventions

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.

lateral position group

supine position PROCEDURE

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

the supine position group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Peng Liang, PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Peng Liang, PhD

CONTACT

18980602201; liangpengwch@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: August 6, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 27, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)