The Role of Capnography in Endoscopy Patients Undergoing Nurse Administered Propofol Sedation (NAPS): A Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxia
- Sponsor
- University Hospital, Gentofte, Copenhagen
- Enrollment
- 591
- Locations
- 1
- Primary Endpoint
- The number of hypoxic events
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Propofol is widely used by anaesthesiologists for deep sedation and general anaesthesia. During recent years nurses trained in the use of low dose Propofol sedation (NAPS) during endoscopy have been introduced. The method has been implemented at the endoscopic unit at Gentofte hospital since 2008(1). Propofol has a respiratory depressive effect which may result in depressed oxygen saturation in the blood (hypoxia). Due to a short acting half life this is prevented in the majority of cases. However, in spite of this, hypoxia is experienced in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished data). It is well known that hypoxia constitutes a late expression of reduced oxygen tension in peripheral tissues. Whether the addition of capnography to standard monitoring during NAPS may be of benefit is widely unknown. The aim of this study is to examine whether the additional use of capnography to standard monitoring during endoscopy may improve patient safety in patients undergoing low dose Propofol sedation by reducing the number, duration and level of hypoxic events. The trial is a randomized clinical prospective case-control study.
Investigators
Charlotte Slagelse
Medical Student
University Hospital, Gentofte, Copenhagen
Eligibility Criteria
Inclusion Criteria
- •aged 18 or above
- •compliant with the criteria of NAPS.
Exclusion Criteria
- •no signed written consent obtained
- •American Society of Anaesthesiologists (ASA) physical status classification \> 3
- •sleep apnoea
- •allergy against soy, eggs and peanuts
- •body Mass Index (BMI) \> 35 kg/m2
- •mallampati Score ≥ 4
- •acute gastrointestinal bleeding
- •ventricular retention
- •severe COLD ((30% ≤ FEV1 \<50%)
- •failed data collection
Outcomes
Primary Outcomes
The number of hypoxic events
Time Frame: The sum of events registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)
If the addition of capnography to standard monitoring can reduce the number of hypoxic events in patients undergoing endscopy with NAPS. A hypoxic event is defined as an observed oxygen saturation of less than 92% . Data is collected by a computer with intervals of 12 sec as the smallest possible.
Secondary Outcomes
- The duration of hypoxia(The sum of time with hypoxia registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes))
- The level of hypoxia(The sum of events registered at each level during procedures (procedure duration is, depending on the type, 3 to 90 minutes))
- Actions taken against respiratory insufficiency(Registered during procedure(procedure duration is, depending on the type, 3 to 90 minutes))