Optimising the clinical application of capnography for monitoring ventilation of sedated patients in the cardiac catheterisation laboratory

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001132437
• Date of registration: 19/08/2016
• Prospective Registration: No
• Primary sponsor: Queensland University of Technology
• Public title: Optimising the clinical application of capnography for monitoring ventilation of sedated patients in the cardiac catheterisation laboratory
• Scientific title: Optimising the clinical application of capnography for monitoring ventilation of sedated patients in the cardiac catheterisation laboratory
• Date of first enrolment: 15/08/2016
• Target sample size: 200
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001132437.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Aaron Conway

• Name: Dr Aaron Conway

Key inclusion & exclusion criteria

Inclusion criteria: Patients undergoing an elective procedure with moderate sedation (intravenous midazolam or midazolam and fentanyl) without an anaesthetist present in a cardiac catheterisation laboratory

Exclusion criteria: 1. less than 18 years of age;
2. cognitively impaired (due to inability to provide informed consent); or
3. unable to understand and speak English (due to inability to provide written informed consent).

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Anaesthetics

sedation-induced respiratory depression;
sedation-induced respiratory depression

Respiratory - Other respiratory disorders / diseases

Intervention(s)

Alterations in capnography waveforms and end-tidal carbon dioxide levels observed during procedures performed in a cardiac catheterisation laboratory with nurse-administered sedation (midazolam or midazolam plus fentanyl) will be used to measure the incidence and duration of episodes of sedation-induced respiratory depression (e.g. hypoventilation and apnoea). Capnography waveforms and end-tidal carbon dioxide levels will be measured from the start to the end of the procedures. These measurements are available to the clinicians (nurses and cardiologists) monitoring patients during procedures and as such may influence treatment decisions.

Primary Outcome(s)

Duration in seconds of hypoventilation caused by partial airway obstruction (defined as a decrease in ETCO2 levels of >10% from baseline that improves with airway repositioning) whilst sedated (defined as OAA/S 4 or less);[Continuous measurements taken every second commence approximately 5 minutes prior to the start of the procedure and are ceased at the end of the procedure]

Duration in seconds of hypoventilation caused by reduced tidal volume respiration (defined as a decrease in ETCO2 levels of >10% from baseline that does not improve with airway repositioning or an increase in ETCO2 levels of >10% from baseline) whilst sedated (defined as OAA/S 4 or less)[Continuous capnography measurements taken every second commence approximately 5 minutes prior to the start of the procedure and are ceased at the end of the procedure]

Duration in seconds of bradypnoeic hypoventilation (defined as respiratory rate of less than 10 breaths per minute) whilst sedated (defined as OAA/S 4 or less)[Continuous capnography measurements taken every second commence approximately 5 minutes prior to the start of the procedure and are ceased at the end of the procedure]

Secondary Outcome(s)

Mean transcutaneous carbon dioxide level whilst sedated (defined as OAA/S 4 or less) using the Sentec Digital Monitoring System with VSign 2 sensor.[Continuous measurements taken every second, which commence approximately 10 minutes prior to the start of the procedure and are ceased at the end of the procedure. ]

Cardiovascular complications (from medical chart review) defined as i. Cardiac arrest (defined as ventricular fibrillation, asystole, electromechanical dissociation or ventricular tachycardia without cardiac output that required cardiopulmonary resuscitation and cardioversion); or ii. Myocardial infarction (defined as confirmed myocardial infarction distinct from index event)[30 days post-procedure]

Disability-free survival (measured with the World Health Organization Disability Assessment Schedule 2.0)[30 days post-procedure]

Post-operative pulmonary complications (from a medical chart review), defined as: a. Respiratory infection that required treatment with antibiotics; b. Pleural effusion confirmed by chest radiograph radiologist report; c. Atelectasis confirmed by chest radiograph radiologist report; c. Pneumothorax confirmed by chest radiograph radiologist report; d. Bronchospasm (newly detected expiratory wheezing treated with bronchodilators); e. Aspiration pneumonitis (Respiratory failure after the inhalation of regurgitated
gastric contents).[30 days post-procedure]

*Primary outcome: Duration in seconds of apnoea (defined as absence of capnography waveform) whilst sedated (defined as OAA/S 4 or less)[Continuous capnography measurements taken every second commence approximately 5 minutes prior to the start of the procedure and are ceased at the end of the procedure]

*Primary outcome: Duration in seconds of hypoxaemia throughout the procedure (defined as percentage of haemoglobin that is saturated with oxygen [SpO2] is less than 90%)whilst sedated (defined as OAA/S 4 or less)[Continuous SpO2 measurements taken every second commence approximately 10 minutes prior to the start of the procedure and are ceased at the end of the procedure]

Secondary ID(s)

None known

Source(s) of Monetary Support

Wesley Medical Research

Ethics review

Status: Approved
Approval date:
Contact:

UnitingCare Health Human Research Ethics Committee