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Evaluation of the clinical application of TcPCO2 measurements during rigid laryngoscopy or microlaryngeal surgery in children

Evaluation of the clinical application of TcPCO2 measurements during rigid laryngoscopy or microlaryngeal surgery in children - TcPCO2 during laryngeal procedures in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50287
Enrollment
140
Registered
2017-10-26
Start date
2019-01-04
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Upper respiratory tract problems requiring surgery

Interventions

During the thirty minutes prior to the planned rigid laryngoscopy or microlaryngeal surgery, during the procedure and during the 30 minutes after the procedure transcutaneous CO2 levels will be meas

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Patient is up to 18 years of age. Indication to undergo a rigid laryngoscopic and/or microlaryngeal procedure. Adequate end-tidal carbon dioxide measurements are unlikely during the planned procedure.

Exclusion criteria

Exclusion criteria: Patient is older than 18 years of age Procedure is carried out while patient is intubated. Patient has a tracheal canula

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the quantification of the effect of the clinical introduction of transcutaneous carbon dioxide monitoring during laryngoscopic and microlaryngeal procedures in children. Therefore, the main study parameter is the cumulative carbon dioxide load / shortage, as a fraction of the monitoring time and will be compared between the *pre* and *post* timeframes.

Secondary

MeasureTime frame
- The effect of adequate carbon dioxide management on the required fraction of inspired oxygen (FiO2) and the resulting SpO2 and cerebral NIRS levels (in patients in which cerebral NIRS measurements were performed). - The amount of use of different types of ventilation (e.g. manual, jet ventilation, spontaneous breathing) during these procedures in relation to the availability of tcPCO2 monitoring. The timing of the application of these ventilation methods is also compared. - The influence of patient age on measurements. - The influence of patient age on the effect of the availability of tcPCO2 monitoring. - The effects of carbon dioxide management without and with transcutaneous tcPCO2 monitoring on vital parameters such as blood pressure and heart rate. - The occurrence of skin effects during transcutaneous monitoring. - The effect of the availability of tcpCO2 monitoring on procedure length and time required to stabilise the patient between procedure steps. - The learning curve of anesthesiologists using transcutaneous carbon dioxide monitoring in terms of changing the timing of the application of different ventilation methods. - The consequences of the introduction of transcutaneous monitoring on clinical practice as evaluated by a questionnaire. - Comparison of the transcutaneously measured values to eventual blood gas samples that are taken as part of clinical care. - Comparison of the end-tidal CO2 values that are obtained in some instances to the tcPCO2 values.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)