Aims Upper gastrointestinal endoscopy (UGE) performed under sedation carries an inherent
risk of respiratory compromise, making effective oxygen support essential for patient
safety ([1]
[2]). While nasal cannulas are the standard of care, their limitations in providing
consistent oxygenation, especially in high-risk or prolonged cases, have prompted
the exploration of alternative strategies ([3],4). The endoscopic face mask (EFM) offers a novel approach, potentially enhancing
oxygenation efficiency without interfering with the endoscopic procedure (5,6). The
RESPIRAR Trial was designed to compare the efficacy and safety of EFM vs conventional
nasal cannulas (CNC) in patients undergoing sedated UGE. This study aims to provide
critical insights into the performance of these oxygen support methods, assessing
key outcomes such as oxygenation levels, incidence of desaturation, and associated
risks, to inform best practices in respiratory management during endoscopic procedures
([3],5)
Methods A single-centre, randomised interventional trial that enrolled patients undergoing
UGE-induced propofol sedation. Participants were randomly assigned to receive oxygen
support via either a CNC or an EFM. Vital signs were collected electronically throughout
and after the procedure. An ad-hoc patient-reported experience measurement (PREEM)
survey was blindly performed. Randomization ensured balanced allocation and statistical
analysis was also blindly carried out to compare outcomes between the two groups.
Results Seventy patients were enrolled: 35 underwent UGE using the EFM and 35 to the CNC
group. The median age was 60 yo, 51 female (72.9%), median BMI of 27.1, highest Mallampati
score of III in 9 (12.9%), and highest Anaesthesiology Society Association (ASA) presurgical
score of III in 5 (7.1%). A low rate of smoking and vaping was documented in 2 (2.9%)
and 1 (1.4%), but alcohol intake in 19 (27.1%). There was no statistical difference
in these baseline characteristics among study groups. Throughout the UEG and post-UEG
anaesthesia recovery period, analysis of the variance (ANOVA) determined in both study
groups a significant diminution in systolic arterial pressure (SAP) from 122 to 71.1
mmHg (p=.004), median arterial pressure (MAP) from 86.8 to 48.8 mmHg (p<.001), respiratory
rate (RR) from 18.3 to 12 breaths per minute (BPM) (p=.0396), and Aldrete score from
10 to 4.5 (p=.002). However, seven cases of desaturation were detected in the CNC
patients (20%), they required to be switched to EFM (p=.296). There was no significant
difference in the proportion of other adverse events. Median anaesthesia length was
34 and 36 minutes in EFM and CNC, respectively (p=.787). PREEM survey showed that
in CNC vs EFM patients, there was a significantly higher rate of pain perception (77.1%
vs 85.7%; p=.0498), hoarseness (11.4% vs 9%; p=.0341), while a significantly higher
rate of EFM patients reported continuing directly to occupational activities after
UGE (25.7% vs 5.7%; p=.04).
Conclusions EFM is a useful device not only for the endoscopist's maneuverability but also offers
the patient more comfortable oxygen support, which results in a better healthcare
experience.
