RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-12-20
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06117683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.
  2. * American Society of Anesthesiologists physical status 1 and 2
  1. * ASA PS \>3 (e.g., respiratory disease)
  2. * Oropharyngeal or facial pathology

Contacts and Locations

Study Contact

Stephanie Farias
CONTACT
401-444-5172
stephanie.farias@lifespan.org
Mark Brady, MD
CONTACT
mark.brady@brownphysicians.org

Principal Investigator

Mark Kendall, MD
PRINCIPAL_INVESTIGATOR
Rhode Island Hospital

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • Mark Kendall, MD, PRINCIPAL_INVESTIGATOR, Rhode Island Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-12-20
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Mechanical Ventilation
  • General Anesthesia
  • Bag Mask Ventilation
  • Adult Sotair Device

Additional Relevant MeSH Terms

  • Airway Management
  • Respiration, Artificial