COMPLETED

Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

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 to 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 superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

Official Title

A Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Manual Ventilation Alone in Patients Undergoing Non-emergent Surgery With General Anesthesia: A Prospective Randomized Cross-over Clinical Trial

Quick Facts

Study Start:2024-05-09
Study Completion:2025-03-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06261619

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 (w/artificial airway) at Rhode Island Hospital.
  2. * American Society Of Anesthesiologists Physical Status 1 and 2
  1. * American Society of Anesthesiologists Physical Status \>3 (e.g. respiratory disease)
  2. * Oropharyngeal or facial pathology

Contacts and Locations

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 Date2024-05-09
Study Completion Date2025-03-18

Study Record Updates

Study Start Date2024-05-09
Study Completion Date2025-03-18

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