Development and validation of a theoretical test in non-anaesthesiologist-administered propofol sedation for gastrointestinal endoscopy.

OBJECTIVE: Safety with non-anaesthesiologist-administered propofol sedation (NAAP) during gastrointestinal (GI) endoscopy is related to theoretical knowledge. A summative testing of knowledge before attempting supervised nurse-administered propofol sedation (NAPS) in the clinic is advised. The aims of this study were to develop a theoretical test about propofol sedation, to gather validity evidence for the test and to measure the effect of a NAPS-specific training course. MATERIAL AND METHODS: A three-phased psychometric study on multiple choice questionnaire (MCQ) test development, gathering of validity evidence and evaluation of the effect of a specific NAAP course on the test result. A MCQ containing 86 questions was developed and administered 113 times to 91 participants representing novices, intermediates and experienced. RESULTS: Question difficulty analyses revealed 50 level I and II questions. The 50 MCQs showed mean (SD) intergroup differences (p = 0.001) between novices = 28.6 (4.82), intermediates = 36.8 (5.43) and experienced = 41.8 (4.65) and provided a pass score of 35.2. The course with pre-course test had significant effect on the knowledge of nurses (18% increase) and physicians (19% increase; p = 0.001 and 0.001, respectively). CONCLUSIONS: Data supported the validity of the developed MCQ test. The NAPS-specific course with pre-course testing adds theoretical knowledge to already well-prepared participants.

Endoscopy nurse-administered propofol sedation performance. Development of an assessment tool and a reliability testing model.

OBJECTIVE: A gold standard of skills required for nurse-administered propofol sedation (NAPS) for gastroenterological endoscopic procedures has been proposed but not established. Due to the potentially hazardous nature of NAPS, an assessment tool is needed to objectively judge the adequacy of training and for future certification. The aim of this study was to develop an assessment tool for measuring competency in propofol sedation and to explore the reliability and validity of the tool. MATERIAL AND METHODS: The nurse-administered propofol assessment tool (NAPSAT) was developed in a Delphi-like fashion. Consensus was achieved on 17 items. Validity evidence was gathered in a case-control study in a full-scale simulation setting. Six experienced nurses and six novice nurses were filmed in two scenarios for assessment according to the assessment tool by three content expert raters. RESULTS: A total of 72 NAPSAT assessment forms were analyzed. Inter-rater reliability, Cronbach's α = 0.54 and generalizability coefficient = 0.68. The experienced nurses scored higher than the novices, 52.8 versus 62.7, p = 0.009. The provided pass/borderline/fail assessment showed significant difference, p = < 0.001, Cronbach's α = 0.80, with the novices being more likely to fail and the experienced more likely to pass. CONCLUSION: Assessing sedation skills in a simulator is possible. Video assessment requires expert knowledge of the procedure and the rating matrix. Overall, NAPSAT showed fair inter-rater reliability and good construct validity. This makes NAPSAT fit for formative assessment and proficiency feedback; however, high stakes and summative assessment cannot be advised.

The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: a randomized study.

OBJECTIVE. Standard benzodiazepine/opioid cocktail has proven inferior to propofol sedation during complicated endoscopic procedures and in low-tolerance patients. Propofol is a short-acting hypnotic with a potential risk of respiratory depression at levels of moderate to deep sedation. The existing literature on capnography for endoscopy patients sedated with nurse-administered propofol sedation (NAPS) is limited. Can the addition of capnography to standard monitoring during endoscopy with NAPS reduce the number, duration, and level of hypoxia. MATERIALS AND METHODS. This study was a randomized controlled trial with an intervention group (capnography) and a control group (without capnography). Eligible subjects were consecutive patients for endoscopy at Gentofte Hospital compliant with the criteria of NAPS. RESULTS. Five hundred and forty patients, 263 with capnography and 277 without capnography, were included in the analysis. The number and total duration of hypoxia was reduced by 39.3% and 21.1% in the intervention group compared to the control group (p > 0.05). No differences in actions taken against insufficient respiration were found. Changes in end-tidal carbon dioxide (R = 0.177, p-value < 0.001) and respiratory rate (R = 0.092, p-value < 0.001) were correlated to oxygen saturation (SpO2) up to 36 s prior to changes in SpO2. CONCLUSIONS. Capnography seems to reduce the number and duration of hypoxia in NAPS patients (p > 0.05). Capnography is able to detect insufficient respiration that may lead to hypoxia prior to changes in pulse oximetry. However, due to a limited clinical benefit and additional costs associated with capnography, we do not find capnography necessary during the use of NAPS.

Nurse-administered propofol sedation for gastrointestinal endoscopic procedures: first Nordic results from implementation of a structured training program.

INTRODUCTION: Proper training to improve safety of NAPS (nurse-administered propofol sedation) is essential. OBJECTIVE: To communicate our experience with a training program of NAPS. MATERIALS AND METHODS: In 2007, a training program was introduced for endoscopists and endoscopy nurses in collaboration with the Department of Anaesthesiology. During a 2.5-year period, eight nurses were trained. Propofol was given as monotherapy. The training program for nurses consisted of a 6-week course including theoretical and practical training whereas the training program for endoscopists consisted of 2.5 h of theory. Patients were selected based on strict criteria including patients in ASA (American Society of Anesthesiologists) group I-III. RESULTS: 2527 patients undergoing 2.656 gastrointestinal endoscopic procedures were included. The patients were ASA group I, II and III in 34.7%, 56% and 9,3%, respectively. Median dose of propofol was 300 mg. No mortality was noted. 119 of 2527 patients developed short lasting hypoxia (4.7%); 61 (2.4%) needed suction; 22 (0.9%) required bag-mask ventilation and 8 (0.3%) procedures had to be discontinued. In 11 patients (0.4%), anesthetic assistance was called due to short lasting desaturation. 34 patients (1.3%) experienced a change in blood pressure greater than 30%. CONCLUSION: NAPS provided by properly trained nurses according to the present protocol is safe and only associated with a minor risk (short lasting hypoxia 4.7%). National or international structured training programs are at present few or non-existing. The present training program has documented its value and is suggested as the basis for the current development of guidelines.

High efficacy with deep nurse-administered propofol sedation for advanced gastroenterologic endoscopic procedures.

BACKGROUND AND STUDY AIMS: Whereas data on moderate nurse-administered propofol sedation (NAPS) efficacy and safety for standard endoscopy is abundant, few reports on the use of deep sedation by endoscopy nurses during advanced endoscopy, such as Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound (EUS) are available and potential benefits or hazards remain unclear. The aims of this study were to investigate the efficacy of intermittent deep sedation with propofol for a large cohort of advanced endoscopies and to provide data on the safety. PATIENTS AND METHODS: All available data from patients sedated with intermittent deep NAPS for ERCP, EUS or double balloon enteroscopy (DBE, since the method was implemented in May 2007 through December 2012 were included for evaluation in a retrospective case-control design. RESULTS: Data from 1899 patients undergoing 1899 procedures were included for evaluation. All but one procedure were completed with intermittent deep NAPS. The mean propofol dose was 397 mg (SD: 232.4) and the infusion rate was 23.9 mg/kg. The frequency of hypoxia was 4.3 % and 20 patients needed assisted ventilation (1.1 %). Anesthesiologic support was requested eight times (0.4 %). One patient was intubated due to suspected aspiration. CONCLUSIONS: Intermittent deep NAPS for advanced endoscopies in selected patients provided an almost 100 % success rate. However, the rate of hypoxia, hypotension and respiratory support was high compared with previously published data, but the method was still assessed as safe.

Moderate and deep nurse-administered propofol sedation is safe.

INTRODUCTION: Non-anaesthesiologist-administered propofol sedation (NAPS/NAAP) is increasingly used in many countries. Most regimens aim for light or moderate sedation. Little evidence on safety of deep NAPS sedation is available. The aim of this study was to explore the safety of intermittent deep sedation with NAPS in patients undergoing gastroenterologic endoscopic procedures. METHODS: This was a retrospective case-control study. All patients sedated with NAPS for colonoscopies, sigmoidoscopies and oesophagogastroduodenoscopies from May 2007 through December 2012 were included. Cases were defined as patients developing an adverse event (oxygen saturation < 92%, a drop in mean arterial pressure of > 30% or a drop in systolic blood pressure of > 50 mmHg). The remaining patients served as controls. RESULTS: A total of 6,840 consecutive patients undergoing 7,364 procedures were included. The mean propofol dose was 331.6 mg (standard deviation = 179.4 mg). The overall rate of hypoxia was 3.2%, and the rate of hypotension was 3.1%. Assisted ventilation was needed in 0.5%. Age (p < 0.001), American Society of Anesthesiologists (ASA) class 3 (p = 0.017) and total propofol dose (p = 0.001) were associated with a higher rate of adverse events. CONCLUSION: Safety during intermittent deep sedation with NAPS was good. Age, ASA class 3 and total propofol dose were correlated with a higher rate of adverse events. Patients aged 60 years or more needed more handling during adverse events. FUNDING: Arvid Nilsson's Foundation provided funding for this study. The founders did not have any influence on the design or the presentation of the study. TRIAL REGISTRATION: not relevant.

Nurse administered propofol sedation for pulmonary endoscopies requires a specific protocol.

INTRODUCTION: This study provides an evaluation and risk analysis of propofol sedation for endoscopic pulmonary procedures according to our unit's "gastroenterologic nurse-administered propofol sedation (NAPS) guideline". MATERIAL AND METHODS: The present study is a prospective descriptive study performed at the Endoscopy Unit, Gentofte Hospital, Copenhagen, from May to July 2009. The study comprised at total of 51 consecutive patients who underwent 77 endoscopic procedures. Only patients above the age of 16 years were eligible for treatment. The exclusion criteria were as follows: American Society of Anesthesiologists (ASA) class > 3, history of sedation-related complications, severe chronic obstructive pulmonary disease. Excluded were patients with a potentially difficult airway and ventricular retention. Data on the number and type of procedure, baseline characteristics, sedation time, propofol dose administered and adverse events were obtained from medical histories. RESULTS: A total of 23 cases of adverse events were recorded, including one event of hypotension and 22 events of hypoxaemia. Five patients needed assisted ventilation. The frequency of hypoxaemia in sessions involving bronchoscopy was 17 of 26 (65%) compared with transoesophageal endoscopic ultrasound (EUS) (17 of 45, 35%) and endoscopic bronchial ultrasound (EBUS) (three of six, 50%). Endoscopist assessment of working conditions was good and patient assessment of discomfort was low. No patients required endotracheal intubation and there was no mortality. CONCLUSION: This study supports the conclusion that propofol administered by nurses provides for good working conditions and satisfied patients. But our "NAPS for endoscopic gastroenterologic procedures" guideline was unsuited for endoscopic pulmonary procedures including EUS. FUNDING: This work was supported by the START research foundation at Gentofte Hospital. TRIAL REGISTRATION: not relevant.

[Propofol sedation administered by nurses for endoscopic procedures]. / Sygeplejerskeadministreret propofolsedation i forbindelse med endoskopi.

INTRODUCTION: As an increasing number of therapeutic and diagnostic procedures are performed endoscopically, the demand for sufficient sedation during endoscopy is rising. Propofol sedation administered by nurses (NAPS) has gained increasing popularity. NAPS was introduced at Gentofte Hospital in September 2007 after structured training at Roque Valley Surgical Center in Medford, Oregon, USA. The aim of the present study is to present our results with NAPS. MATERIAL AND METHODS: Patients referred for endoscopy were monitored with regard to blood pressure, pulse oxymetry, electrocardiography and evaluation of their respiration during and after the procedure. RESULTS: A total of 229 patients (233 endoscopic procedures) were included (ASA I: 68 (29%), ASA II: 116 (50%), ASA III: 44 (19%), ASA IV: 1 (0.4%)). The median propofol administration was 330 mg (variance 100-1,700 mg). Hypoxia, defined as oxygen < 92%, was observed in 18 patients. The hypoxia lasted less than 30 seconds in eight patients and between 30-60 seconds in eight cases. Two patients had hypoxia for a period exceeding 60 seconds. Propofol administration was discontinued in all 18 cases and increased oxygen flow was administered via a nasal tube. Short lasting manual mask ventilation was instituted in five patients. No serious events related to sedation were seen. CONCLUSIONS: NAPS seem to be a suitable method for sedation in endoscopy and should be implemented in Denmark. However, proper training is required in collaboration with anaesthesiologists.