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NCT Number: NCT07644793

Litter Packaging in the Lateral Position: Effects of Position and Vacuum Mattress Packaging on Pulmonary Function

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

Fresno, California, 93701, United States

About this study

After acknowledging informed consent, each subject will do baseline sitting pulse oximetry (device) and forced vital capacity (FVC) and 1-second forced expiratory volume (FEV1) three times. After obtaining a baseline, the subject will be secured with a MedTech-VSB 6 foot vacuum mattress (MedTechSweden, Geneseo, IL) in a Ferno-Washington Model 71 litter (Ferno-Washington, Wilmington, OH) using 1-inch tubular webbing, following the methodology of the National Cave Rescue Commission but with no padding and no blankets, see figure 1 .8 The mattress will be deflated (stiffened) to start after securing into the litter with webbing. The litter will be rigged for suspension in the horizontal supine and horizontal lateral positions. We will measure FEV1 and FVC will be repeated in each of 4 positions; supine on a non-stiffened mattress in a horizontal litter (see figure 1), supine on a stiffened mattress in a horizontal litter, in lateral decubitus position in a stiffened mattress in a horizontal litter (see figure 2), and supine, with a stiffened mattress in a vertical litter. The order will be randomly assigned to eliminate any learning effect. The calculated sample size is 10, which should be easily enough to see a difference between baseline and just lying flat. The anticipated change in pulmonary function in the mattress will be in addition to lying down, but not as big as this. So to find this smaller change we anticipate needing 24, this allows for doing all 24 potiential orders of 4 procedures. We will do a preliminary analysis after 12 person, but will continue to 24 if there is no demonstrated difference with the mattress at 12, (see Table 1). In each case, the patient will stay in the position for 1 minute after completing spirometry to measure oxygen saturation again.

1,2,3,4 2,1,3,4 3,1,2,4 4,1,2,3 1,2,4,3 2,1,4,3 3,1,4,2 4,1,3,2 1,3,2,4 2,3,1,4 3,2,1,4 4,2,1,3 1,3,4,2 2,3,4,1 3,2,4,1 4,2,3,1 1,4,2,3 2,4,1,3 3,4,1,2 4,3,1,2 1,4,3,2 2,4,3,1 3,4,2,1 4,3,2,1 Table 1, orders of testing

The litter will be raised 6 inches off of the ground prior to measurement. Anchors to support his will be the patio sun structure at UCSF which has been approved by local building supervisors and used for several other trials, or using trees at other sites. The PI and co-PIs have extensive training and experience evaluating anchors for life support in technical rope exercises. We will not use a crash pad in this set of experiments as the subject will be no more than 6 inches off of the ground and a six inch thick pad will make it harder to quickly intervene even if something did go wrong.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Patient packaging in a rescue litter

Other

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

Primary outcomes

  1. Forced Vital Capacity

    Time frame: 1 hour

    Forced Vital Capacity

  2. 1 second forced vital capacity

    Time frame: 1 hour

    1 second forced vital capacity

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Horwege, MSHCA

CONTACT

[email protected]

5594996450

Roger B Mortimer, MD

CONTACT

[email protected]

15594996450

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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