NCT07644793

Brief Summary

This is a study to look at the effect on breathing of various ways to package a person in a rescue litter. We will measure lung function in a litter, lying down, lying down in a vacuum mattress, one the side in a vaccum mattress, and vertical in a vacuum mattress.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

pulmonary functionsearch and rescuetrauma

Outcome Measures

Primary Outcomes (2)

  • Forced Vital Capacity

    Forced Vital Capacity

    1 hour

  • 1 second forced vital capacity

    1 second forced vital capacity

    1 hour

Study Arms (1)

Comparison of pulmonary function by litter packaging

EXPERIMENTAL

Order of packaging

Other: Patient packaging in a rescue litter

Interventions

Different packaging paradigms in a rescue litter done in a random order.

Comparison of pulmonary function by litter packaging

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be 18 to 65 years old. Per the harness manufacturer's recommendation, participants must weigh between 130 and 300 pounds and have a waist between 32 and 42 inches.

You may not qualify if:

  • Weight greater than 300 pounds or less than 130 pounds, pregnancy, any known heart condition or murmur or lower extremity edema or wheezing detected on pre-participation exam, or a waist size \<32" or \>42". Prior to suspension, female participants of childbearing potential will self-administer an FDA approved urine pregnancy test supplied by the investigator. Results will be verified by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

Fresno, California, 93701, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Roger B Mortimer, MD

    UCSF - Fresno

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger B Mortimer, MD

CONTACT

Michelle Horwege, MSHCA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: This is an unblinded, randomized crossover study using 12-24 health volunteer subjects. All subjects will do baseline pulmonary testing. Experimental order is balanced to avoid training effects. Choice of sequence will be by random selection of envelope.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations