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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07644793
Enrollment
24
Registered
2026-06-12
Start date
2026-08-15
Completion date
2026-12-31
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Keywords

pulmonary function, search and rescue, trauma

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.

Detailed description

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.

Interventions

OTHERPatient packaging in a rescue litter

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

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Forced Vital Capacity1 hourForced Vital Capacity
1 second forced vital capacity1 hour1 second forced vital capacity

Countries

United States

Contacts

CONTACTRoger B Mortimer, MD
roger.mortimer@ucsf.edu15594996450
CONTACTMichelle Horwege, MSHCA
michelle.horwege@ucsf.edu5594996450
PRINCIPAL_INVESTIGATORRoger B Mortimer, MD

UCSF - Fresno

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026