TraumaNCT07644793
Litter Packaging in the Lateral Position: Effects of Position and Vacuum Mattress Packaging on Pulmonary Function
A study testing Patient packaging in a rescue litter in people with Trauma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma
- What is being tested?
- Patient packaging in a rescue litter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
Fresno, California, 93701
About this study
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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Patient packaging in a rescue litter
- Keywords
- pulmonary function, search and rescue, trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient packaging in a rescue litterOther
Different packaging paradigms in a rescue litter done in a random order.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of pulmonary function by litter packaging | Experimental | Order of packaging Receives: Other: Patient packaging in a rescue litter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity
Forced Vital Capacity
Measured: 1 hour
1 second forced vital capacity
1 second forced vital capacity
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger B Mortimer, MD, Principal investigator, UCSF - Fresno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644793
- Sponsor's protocol ID
- 26-46885
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Litter Packaging in the Lateral Position: Effects of Position and Vacuum Mattress Packaging on Pulmonary Function
- ClinicalTrials.gov ID
- NCT07644793
- Acronym / sponsor ID
- 26-46885
- Conditions
- Trauma
- Keywords
- pulmonary function, search and rescue, trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Comparison of pulmonary function by litter packaging | Experimental | Other: Patient packaging in a rescue litterOrder of packaging |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient packaging in a rescue litterDifferent packaging paradigms in a rescue litter done in a random order. | Other | Comparison of pulmonary function by litter packaging |
Primary outcome
Forced Vital Capacity
Time frame: 1 hour
Forced Vital Capacity
1 second forced vital capacity
Time frame: 1 hour
1 second forced vital capacity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roger B Mortimer, MD principal investigator
UCSF - Fresno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient packaging in a rescue litter in people with Trauma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roger B Mortimer, MD (15594996450, roger.mortimer@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.