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Making tonsillectomy surgery safer for children by examining obstructive sleep apnoea

Making Tonsillectomies Safer by examining methods of screening and diagnosis of obstructive sleep apnoea and comparing to airway collapsibility measurements for children undergoing tonsillectomy surgery under general anaesthesia.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617001503314
Acronym
OSATS2
Enrollment
65
Registered
2017-10-25
Start date
2018-02-21
Completion date
2020-08-24
Last updated
2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Obstructive sleep apnoea (OSA) is a condition involving repeated episodes of partial or complete blockage of the airway during sleep. Children diagnosed with OSA usually undergo surgical removal of the tonsils and adenoids. However, there is a high rate of complications with approximately 50% of the children suffering from minor or major breathing problems during and/or after surgery requiring specialised care. Additionally, the younger the children are, the higher the risk of breathing problems. The impact on the healthcare system is significant; the number of unplanned admissions necessitating specialised treatment with prolonged hospital stays increases causing delays on theatre lists. This leads to potential cancellations of other children due to the lack of theatre time and consequently increases the waitlist time. The ‘gold standard’ test for diagnosis and classification of OSA is the complex and expensive technique called polysomnography (PSG) (overnight sleep study). The associated high cost and lengthy waiting list means that it is rarely used in clinical practice in this population. Currently, surgeons and anaesthetists assess the children’s risk of respiratory complications through clinical history and questionnaires. However, relying on parental observations alone can make assessment of the presence and severity of OSA challenging. As a result, this screening technique is not sufficient. Children at an increased risk of respiratory problems can be missed through this process & their airway management strategies may not be conservative enough to minimise the risk of respiratory complications during and after their procedure. Since OSA involves a highly collapsible upper airway during sleep and also anaesthesia, we have adopted a method to measure the likelihood of collapse of the upper airway (throat) under anaesthesia to predict OSA severity. This safe, simple and quick technique, that can be implemented in routine practice will provide anaesthetists with a new screening method and allow evidence-based risk stratification of this high risk population and will allow anaesthetists to tailor their management for the individual patient to avoid breathing problems. Alternatively, children with no/mild obstructive sleep apnoea requiring less close observation following surgery will be able to be discharged earlier reducing the overall emotional impact on families by allowing patients to recover in the comfort and familiarity of their own home. This may also reduce overall unnecessary admissions to ICU alleviating some of the economic impact of this problem on the hospitals. This study will also look at other emerging techniques that may estimate OSA severity to examine if they correlate with PSG data and are predictive for respiratory problems. Ultimately, we aim to develop a clinical guideline from some or all of these parameters that will allow improved stratification of preoperative OSA patients without the reliance on PSG.

Interventions

1: Polysomnography (overnight sleep study) will be performed by an experienced sleep scientist or technician with each participant at 2 time points, first within 3 months prior to surgery and second at 6 to 18 weeks after surgery. 2: A 3D facial picture will be taken with each participant at 2 time points, first within 3 months prior to surgery and second at 6 to 8 weeks after surgery. (at the same time as sleep studies.) 3: ActiCal (ActiCals’s, Philips Respironics) activity monitoring devices

1: Polysomnography (overnight sleep study) will be performed by an experienced sleep scientist or technician with each participant at 2 time points, first within 3 months prior to surgery and second at 6 to 18 weeks after surgery. 2: A 3D facial picture will be taken with each participant at 2 time points, first within 3 months prior to surgery and second at 6 to 8 weeks after surgery. (at the same time as sleep studies.) 3: ActiCal (ActiCals’s, Philips Respironics) activity monitoring devices to be worn at 2 time points. On night of both sleep studies plus 7 nights after each sleep study. They will be applied by the research team member and parents advised on care for device at home. 4: WristOx (Nonin) wrist oxygen saturation device to be worn on night after procedure when in hospital and will be applied by a trained study team member. 5: Measurements of airway collapsibility pressure will be carried out at two different time points. (1) Just after induction of anaesthesia and prior to insertion of the airway device (i.e. prior to the procedure starting) (2) At emergence just after the removal of the airway device (i.e. after the procedure has been completed) Each measurement will be between 15 and 30 seconds and repeated twice to give an accurate result. This involves the use of a nasal mask and requires the patient to be breathing spontaneously while anaesthesia is maintained. A pressure transducer will continuously measures pressure changes within the nasal mask. Airflow and phase of respiratory cycle will be monitored either by a pneumotachograph attached to the nasal mask, or by visually monitoring the patient’s chest wall movement. After ensuring that the nasal mask is leak free by optimising the seal, at end-expiration it will be occluded and the pressure-time profile monitored for evidence of ‘flattening’ - indicating upper airway collapse. (Breathing will be blocked for between 15 to 30 seconds.) The pressure at which this occurs (termed Pclose) will be recorded. Once the flattening of the curve is observed, the nasal mask is removed and breathing returns to normal. Air flow will be monitored for all patients to ensure adherence to the protocol. All results of airway collapsibility will be recorded in a study data collection log. 6: Completion of sleep study questionnaires (Pediatric Sleep Questionnaire/PSQ: Sleep-Disordered Breathing Subscale and the Sleep Disturbances Scale for Children) at 3 timepoints; Both of the sleep studies and on day of procedure. 7: A blood sample will be taken on the day of procedure when the child is anaesthetised to verify the red cell distribution width 8: Validation of Nonin wristox as a diagnostic tool. Monitoring with wristox to pre - and post-surgery sleep studies to allow comparison with the polysomnography data.

Sponsors

Princess Margaret Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
1 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

Male or female Aged 1 to 8 years of age Undergoing elective surgery under general anaesthetic for tonsillectomy (+/- adenoids, myringotomy, insertion of grommets and/or cautery of inferior turbinates)

Exclusion criteria

Need for premedication with midazolam. Contraindication for the use of sevoflurane Inability to give informed consent Children with known cardiopulmonary disease Significant medical disease or condition that is likely to interfere with the protocol or might be confounded by the protocol. • Born less than 32 weeks of gestational age

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026