Menu
Recruiting NCT06117683

Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

No phase Interventional Airway Management Respiration, Artificial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADULT Sotair Device.
Who it may be relevant to
Registry conditions: Airway Management, Respiration, Artificial. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia

Overview

Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.

Detailed description

Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag valve mask (i.e. manual resuscitator) and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this non-inferiority study, a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation with respect to airway pressure.

Interventions

  • Device ADULT Sotair Device
    Sotair® device employs a flow limiting and pressure control valve mechanism.

Primary outcome measures

  • Peak airway pressure [Time frame: Recorded for 3 minute duration for each arm of the study]
Secondary outcome measures (7)
  • Tidal volume [Time frame: Recorded for 3 minute duration for each arm of the study]
  • Airflow [Time frame: Recorded for 3 minute duration for each arm of the study]
  • Respiratory rate [Time frame: Recorded for 3 minute duration for each arm of the study]
  • Oxygen saturation (SpO2) [Time frame: Recorded for 3 minute duration for each arm of the study]
  • End Tidal CO2 [Time frame: Recorded for 3 minute duration for each arm of the study]
  • Blood pressure [Time frame: Recorded for 3 minute duration for each arm of the study]
  • Heart rate [Time frame: Recorded for 3 minute duration for each arm of the study]

Eligibility criteria

Inclusion criteria

  • Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.
  • American Society of Anesthesiologists physical status 1 and 2

Exclusion criteria

  • ASA PS >3 (e.g., respiratory disease)
  • Oropharyngeal or facial pathology

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Rhode Island Hospital — Providence

Publications

  • Fogarty M, Kuck K, Orr J, Sakata D. A comparison of controlled ventilation with a noninvasive ventilator versus traditional mask ventilation. J Clin Monit Comput. 2020 Aug;34(4):771-777. doi: 10.1007/s10877-019-00365-1. Epub 2019 Jul 23. PMID 31338661
  • von Goedecke A, Bowden K, Wenzel V, Keller C, Gabrielli A. Effects of decreasing inspiratory times during simulated bag-valve-mask ventilation. Resuscitation. 2005 Mar;64(3):321-5. doi: 10.1016/j.resuscitation.2004.09.003. PMID 15733761
  • Culbreth RE, Gardenhire DS. Manual bag valve mask ventilation performance among respiratory therapists. Heart Lung. 2021 May-Jun;50(3):471-475. doi: 10.1016/j.hrtlng.2020.10.012. Epub 2020 Nov 1. PMID 33138977
  • Hutten MC, Goos TG, Ophelders D, Nikiforou M, Kuypers E, Willems M, Niemarkt HJ, Dankelman J, Andriessen P, Mohns T, Reiss IK, Kramer BW. Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs. Pediatr Res. 2015 Dec;78(6):657-63. doi: 10.1038/pr.2015.158. Epub 2015 Aug 31. PMID 26322409

Identifiers

NCT: NCT06117683 · 1963885

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗