Efficacy and Risk Analysis of Endoscopic Face Mask vs Cannula in Sedated Upper Endoscopy: The RESPIRAR Trial Insights

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.

Publication History

Article published online:
27 March 2025

• References

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