Design
A descriptive cross-sectional study was carried out at the Digestive Endoscopy Service at the University Hospital of Toledo. The study was conducted following the Strengthening the Reporting of Observation Studies in Epidemiology (STROBE) checklist [24]. The data collection period was June–September 2023.
Participants/Sample
The reference population was adult users over 18 years of age who attended the digestive endoscopy service of Toledo University Hospital to perform endoscopies with sedation.
The inclusion criteria were as follows:
- User of the digestive endoscopy service of the University Hospital of Toledo.
- Digestive endoscopy with sedation.
- American Society of Anesthesiologists (ASA) physical status I-II [25].
- Mallampati classification I-II [26].
- Endoscopic technique: gastroscopy, colonoscopy, or endoscopic ultrasound.
The exclusion criteria were:
- Pediatric patient or dependent on the pediatric service, under 18 years of age.
- Endoscopic technique: endoscopic retrograde cholangiopancreatography
The study area was the endoscopy service of Toledo University Hospital. In this service, endoscopies are performed (gastroscopies, colonoscopies, and digestive echo endoscopies) with sedation by the endoscopy staff only on those over 18 years of age. Therefore, the study population was all legal adults.
The sampling was carried out with the GRANMO program for population estimation, taking as a reference the previous study by Veldhuijzen et al. [27], in which users reported a total satisfaction score of 79.6 out of 100 points. Therefore, a random sample of 278 individuals would be enough to estimate, with a confidence of 95% and a precision of ±5 percentage points, a population percentage that will foreseeably be around 79.6%. A replacement rate of 10% was established. The final sample consisted of 660 subjects.
Variables
The following independent variables were collected: age, sex, weight, height, allergies, abdominal surgeries, important diseases and/or diseases of interest, habitual medication, consent, ASA classification, and Mallampati classification.
In turn, the following variables related to patient satisfaction with the service were analyzed: waiting time for the test, care provided by the medical staff, care provided by the nursing staff, quality of the information received, and discomfort during the test.
Instruments
The data collection instruments used were the medical records of the patients and a satisfaction questionnaire that the users completed. The specific instruments were the following:
- Digestive endoscopy service satisfaction survey. We used the validated Spanish version [28] of the questionnaire on patient satisfaction with gastrointestinal endoscopy put forth by the American Society of Gastrointestinal Endoscopy (GHAA-9 m) [29]. This survey evaluated the quality and results of gastrointestinal endoscopy.
- Endoscopy control and treatment sheet. This tool is commonly used in the endoscopy service of the University Hospital of Toledo. This document collects sociodemographic data of the patient, such as sex and age, as well as information about pathologies and diseases that must be taken into account to carry out the technique safely and effectively, such as lung, heart, kidney disease, intervention procedures, allergies and pharmacological treatment. It also collects the medication and dose administered for sedation. Finally, this sheet contains a section where some constants, such as oxygen saturation (SatO2), blood pressure (BP), and heart rate, are collected (HR) before sedation, during sedation, and after sedation, as well as levels of consciousness, recovery after sedation, and incidents. The data on this sheet do not include patient identification; only anonymized clinical data were used.
- Classification of the ASA physical status. This estimates the risk posed by anesthesia for the different states of the patient. It was created by a committee consisting of Meyer Saklad, Ivan Taylor, and Emery Rovenstine [30]. This scale is scored from 1 to 6; patients scoring 3 or more are those who present a certain risk: these are people who have a serious illness. Patients classified as 4 or 5 had severe disease and might not survive more than 24 hours without surgical intervention. Patients classified as 6 had declared brain death, and their organs were removed for donation [25, 31].
- Aldrete scale. It was created by Dr. Aldrete [32]. It is an evaluation scale used to assess patients undergoing general anesthesia and determine their transfer after the immediate recovery of the patient. This scale consists of 5 items. Each item is rated on a Likert-type scale from 0 to 2, with a total range that ranges from 0 to 10. The cutoff point is 9, where a score equal to or greater than this value suggests adequate recovery after anesthesia.
- Mallampati classification. Designed by Mallampati [26], this scale or classification is used to predict the ease of intubation. It is assessed by analyzing the anatomy of the oral cavity. It is based on the visibility of the base of the uvula, the isthmus of the jaws, and the soft palate. A score is determined by the manifesting or not of phonation. A high score (class 4) is associated with difficult intubation, as well as a high incidence of sleep apnea.
Procedure
The patients who met the inclusion criteria were provided with the information sheet and signed the informed consent form if they wished to participate in the study. After the consent was signed and the examination was completed and before discharge, a questionnaire was provided for completion. This questionnaire included a survey of patient satisfaction with the digestive endoscopy service.
The remaining digital clinical history of the patient corresponding to the endoscopy control and treatment sheet was obtained, maintaining the anonymity of these patients and using only clinical data corresponding to the performance of the endoscopic technique and clinical history of interest.
Statistical Analysis
For the statistical analysis, SPSS version 28 program, which is licensed by the University of Castilla-La Mancha, was used. The qualitative variables are expressed as counts (n) and percentages (%). The quantitative variables are expressed as the arithmetic mean (m) and standard deviation (SD). An inferential analysis was performed to determine the relationships of the independent variables with the dependent variables:
For qualitative variables, proportions were compared between groups using the chi-squared test for contingency tables. For 2x2 tables, the chi-squared test with Yates’s correction was used, and when any expected frequency was ≤5, Fisher's exact test was applied.
For the quantitative variables, first the goodness of fit to a normal distribution was determined by the Shapiro‒Wilk test, as was the homogeneity of the variances by the Levene test. If the data fit a normal distribution, Student’s t test was used. Otherwise, their corresponding nonparametric test Mann‒Whitney U was applied.
All hypothesis tests are bilateral. In all the statistical tests, statistically significant values were those whose confidence level was 95% (p<0.05).
Ethical Considerations
This study was approved by the Ethics Committee for Clinical Research with Medicines of the "Complejo Hospitalario Universitario de Toledo" on 5/5/23 n° 1012. All participants read the information sheet and signed informed consent to participate in the study.