Value of Capnography During Nurse Administered Propofol Sedation (NAPS)

NCT01507623 | Completed

• 1 other identifier: NAPS_CAPNOGRAPHY1
• Study Type: interventional
• Target: 591
• Locations: 1 country
• Sites: 1

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in spite of this, hypoxia is experienced in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished data).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.

Conditions

Hypoxia

Keywords

NAPS; Hypoxia; Propofol; capnography; endoscopy; Sedation

Outcome Measures

Primary Outcomes (1)

• The number of hypoxic events

  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.

  The sum of events registered during procedures (procedure duration is, depending on the type, 3 to 90 minutes)

Secondary Outcomes (3)

• Actions taken against respiratory insufficiency

  Registered during procedure(procedure duration is, depending on the type, 3 to 90 minutes)

• 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)

Study Arms (2)

With Capnograpy

EXPERIMENTAL

Intervention group with the addition of capnography to standard monitoring (non-invasive blood pressure, pulse, pulse oximetry, clinical observation of respiration, electrocardiography (ECG) and respiratory frequency measured by the ECG)

Device: Capnography (Phillips MP20 monitor)

No Capnography

NO INTERVENTION

Control group without the addition of capnography to standard monitoring (non-invasive blood pressure, pulse, pulse oximetry, clinical observation of respiration, electrocardiography (ECG) and respiratory frequency measured by the ECG)

Interventions

Capnography (Phillips MP20 monitor) DEVICE

In the intervention group the NAPS nurse observed possible hypoxia and changes in capnography curves/values during the procedure and was instructed to decrease propofol and take actions against insufficient ventilation\* if etCO2 ≥ 7kPa or ≤ 2 kPa for ≥ 1 minute, if respiratory frequency ≤ 8 or a loss of curve shape was registered. \*Suction, increase oxygen supply, tongue holder or nasal airway, bag-mask ventilation,paged anaesthesia Discontinued procedures

Also known as: Capnography: Phillips MP20 monitor, Nasal cannulae: Smart CapnoLine GuardianTM

With Capnograpy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 or above
• compliant with the criteria of NAPS.

You may not qualify if:

• 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
• subileus
• ventricular retention
• severe COLD ((30% ≤ FEV1 \<50%)
• failed data collection

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• The Ministry of Science, Technology and Innovation, Denmark: collaborator

Study Sites (1)

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

• Slagelse C, Vilmann P, Hornslet P, Jorgensen HL, Horsted TI. The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: a randomized study. Scand J Gastroenterol. 2013 Oct;48(10):1222-30. doi: 10.3109/00365521.2013.830327. Epub 2013 Sep 2.

  PMID: 23992025 DERIVED

MeSH Terms

Conditions

Hypoxia

Interventions

Capnography

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Peter Vilmann, MD, Prof.

  Herlev and Gentofte University Hospital, Denmark

  STUDY DIRECTOR

• Charlotte Slagelse, Med. student

  Gentofte University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: January 11, 2012
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

DK (1)