Feasibility of performing measurements of airway collapse during tonsillectomy surgery in children.

• Register: ANZCTR
• Last refreshed on: 30 January 2023
• Main ID: ACTRN12615001037594
• Date of registration: 06/10/2015
• Prospective Registration: Yes
• Primary sponsor: Prof Britta Regli-von Ungern-Sternberg
• Public title: Feasibility of performing measurements of airway collapse during tonsillectomy surgery in children.
• Scientific title: Is it feasible to perfom (and repeat) airway collabsibility measurements in the paediatric population who are undergoing tonsillectomy procedures and does this data relate to patients having obstructive sleep apnoea and the associated risk of perioperative respiratory adverse events?
• Date of first enrolment: 07/10/2015
• Target sample size: 56
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001037594.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Britta Regli-von Ungern-Sternberg

• Name: Prof Britta Regli-von Ungern-Sternberg

Key inclusion & exclusion criteria

Inclusion criteria: Male or female
Aged 1 to 8 years of age
Undergoing elective surgery under general anaesthetic for tonsillectomy (+/- adenoids, myringotomy, 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.


Age minimum: 1 Years
Age maximum: 8 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Surgery - Surgical techniques

Respiratory - Sleep apnoea

Respiratory complications under general anaesthetic in children undergoing tonsillectomy (+/-adenoids/grommets) procedures.;
Respiratory complications under general anaesthetic in children undergoing tonsillectomy (+/-adenoids/grommets) procedures.

Anaesthesiology - Anaesthetics

Intervention(s)

Measuring the propensity of upper airway collapse may provide more accurate physiological data to grade Obstructive Sleep Apnoea (OSA) and consequently narrow down the variability in the estimated probability of perioperative respiratory adverse events.
The study will start by the screening for the presence of obstructive sleep apnoea.
Measurements of airway collapsibility pressure will be carried out at two different perioperative phases;
(1) Just after induction of anaesthesia and prior to insertion of the airway device
(2) At emergence just after the removal of the airway device

Upper airway collapsibility pressure will be measured at the above two timepoints. 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.

Primary Outcome(s)

The primary outcome will be identifying whether measuring airway collapsibility measurements are feasible and repeatable in children undergoing tonsillectomy procedures. [Measurements will be completed at 3 time points during the anaesthetic time for the surgical procedure.
(1) Just after induction of anaesthesia and prior to insertion of the airway device
(2) At emergence of anaesthesia, once the procedure is completed and just after the removal of the airway device
(3) In the recovery phase of anaesthesia, prior to the patient being awake.
]

Secondary Outcome(s)

The secondary exploratory outcome will be the associations between the presence and extent of airway collapse and the presence and/or severity of obstructive sleep apnoea.
presence/extent of airway collapse assessed by pressure transducer in nasal mask, and OSA assessed by the PMH Sleep disturbance scale for children completed by parent/carer.[Measurements will be completed at 3 time points during the anaesthetic time for the surgical procedure.
(1) Just after induction of anaesthesia and prior to insertion of the airway device
(2) At emergence of anaesthesia, once the procedure is completed and just after the removal of the airway device
(3) In the recovery phase of anaesthesia, prior to the patient being awake.]

The secondary exploratory outcome will be the associations between the presence and extent of airway collapse and the incidence of perioperative respiratory adverse events (PRAE).
Presence/extent of airway collapse assessed by pressure transducer in nasal mask, and respiratory adverse events as assessed by the anaesthetist throughout the procedure (including bronchospasm, laryngospasm, airway obstruction, severe coughing, oxygen desaturation or stridor).[Measurements will be completed at 3 time points during the anaesthetic time for the surgical procedure.
(1) Just after induction of anaesthesia and prior to insertion of the airway device
(2) At emergence of anaesthesia, once the procedure is completed and just after the removal of the airway device
(3) In the recovery phase of anaesthesia, prior to the patient being awake.
PRAE will be monitored and documented at induction of anaesthesia, during maintenance and emergence of anaesthesia and at the recovery stage after anaesthesia.]

Secondary ID(s)

OSATS: the Obstructive Sleep Apnoea study: making Tonsillectomies Safer

Source(s) of Monetary Support

Princess Margaret Hospital Foundation

Secondary Sponsor(s)

Princess Margaret Hospital

Ethics review

Status: Approved
Approval date: 16/09/2015
Contact:

Princess Margaret Hospital Ethics Committee

Results

• Results available: Yes
• Date Posted: 02/02/2022
• Date Completed: 14/09/2016