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To explore oxygen saturation and sleep quality measurements in children undergoing tonsillectomy surgery.

Enhancing Management of Perioperative High risk paediatric tonsillectomy patients through Assessment of oxygen Saturation and Sleep quality (EMPHASIS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617001379303
Acronym
EMPHASIS
Enrollment
70
Registered
2017-09-28
Start date
2018-02-02
Completion date
2021-11-03
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

Tonsillectomy is one of the most frequently performed surgical procedures in kids, with approximately ½ million/annum in US, mainly performed as day cases. In Australia, in 2012/13, there were 38575 admissions due to tonsillectomies, representing 724 admissions per 100000 people aged 17 years and under. Sleep disordered breathing (SDB), rather than infection has become the primary reason for tonsillectomy. SDB is defined as an abnormal respiratory pattern during sleep. It presents as a spectrum from simple snoring to severe obstructive sleep apnoea (OSA). The incidence of peri-operative respiratory complications is 10 times higher for children with OSA compared to those without OSA. Perioperative respiratory adverse events necessitating a medical intervention occur in about 10% of children undergoing adenotonsillectomy, 60% of these occur in the immediate post-operative period. However, desaturations can continue for an unpredictable further period of time in a substantial number of children following tonsillectomy. Currently the gold standard test for assessing presence and severity of OSA/SDB is polysomnography. It is however, a high cost, labour intensive test and is associated with long waiting lists and therefore rarely used in these children. There has been some research on using preoperative oximetry to stratify a patient’s need for more or less observation (e.g. ambulatory surgery, ward special, ICU). This study will enrol patients scheduled for tonsillectomy and assess their baseline sleep quality via a questionnaire, overnight pulse oximetry and awake-sleep pattern using novel portable activity monitoring devices (ActiCal). These will be performed in the patient’s home prior to surgery. Then any breathing problems within 24 hours of surgery will be recorded. We will then examine if these problems can be predicted from our preoperative measures. If successful this would allow better stratification of risk of patients for tonsillectomy allowing them to get the most appropriate level of post-operative observation required for each individual child. We will then follow the patients with the same monitors for up to 14 nights after surgery to determine the extent/course of improvement provided by surgery to blood oxygen levels and the impact on sleeping pattern. This will also allow better characterisation of the course of a patient’s night time oxygen levels in the days after surgery, and allow examination of the impact of strong pain killers given around surgery on this parameter. This would help clinicians make more informed decisions in relation to length of stay after surgery. Currently there is very little data to inform these decisions or care pathways. Additionally the activity monitors will help us track the child’s return to normal physical activity which has not previously been assessed objectively. This would allow more evidenced based information to be conveyed to parents about typical recovery after tonsillectomy surgery.

Interventions

1.. ActiCal activity monitoring devices (Philips Respironics) 2 are worn by participants on the wrist and hip for 4 consecutive days up to 8 weeks prior to surgery. On the day of surgery, immediately after the surgery, the patients will be fitted with the same monitors again, which they are asked to wear for 10 to 14 days (including nights). 2. Nonin WristOx oxygen saturation device. (Nonin WristOx2, NOX medical)will be worn for 4 consecutive nights up to 8 weeks prior to surgery. On the day of

1.. ActiCal activity monitoring devices (Philips Respironics) 2 are worn by participants on the wrist and hip for 4 consecutive days up to 8 weeks prior to surgery. On the day of surgery, immediately after the surgery, the patients will be fitted with the same monitors again, which they are asked to wear for 10 to 14 days (including nights). 2. Nonin WristOx oxygen saturation device. (Nonin WristOx2, NOX medical)will be worn for 4 consecutive nights up to 8 weeks prior to surgery. On the day of surgery, immediately after the surgery, the patients will be fitted with the same monitors again, which they are asked to wear for 10 to 14 nights. All participants will wear both devices during the same time period.

Sponsors

Perth Children's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

Male or female, aged 3 to 10 years of age Undergoing elective surgery under general anaesthetic for tonsillectomy (+/- adenoids, myringotomy, insertion of grommets and/or cautery of inferior turbinates surgery)

Exclusion criteria

Inability to give informed consent Children with known significant cardiopulmonary disease Significant medical disease or condition that is likely to interfere with the protocol or might be confounded by the protocol.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026