Lateral Positioning for Extubation After Adenotonsillectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorSichuan University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
lateral postion
Procedure/SurgeryThe 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 position
Procedure/SurgeryThe children will be changed to a supine flat-lying position for extubation.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: lateral position groupExperimental treatment 1 intervention
Group B: the supine position groupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
during PACUSecondary outcomes
1
Frequency of PRAEs
Frequency of PRAEs: Record the category and count of each PRAE occurring in each child.
Time frame
during PACU2
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 PACU3
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 PACU4
PACU stay duration
PACU stay duration: time from PACU admission until meeting PACU discharge criteria(\*Aldrete score ≥9/10)
Time frame
during PACUOther outcomes
1
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 PACU2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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