Pulmonary Function by Litter Position
Study Overview
Status
Intervention / Treatment
Detailed Description
Objective To quantify changes in pulmonary function tests (PFTs) based on litter position.
Hypotheses:
- Compared to sitting baseline, all PFTs in the litter will have decreased forced vital capacity (FVC) and 1 second forced expiratory volume (FEV1).
- Compared to lying down, persons straight upright and pitched forward will have better forced vital capacity (FVC) and 1 second forced expiratory volume (FEV1).
- We do not hypothesize any changes in FEV1/FVC.
Study Design This randomized crossover study will use twelve healthy volunteers. All subjects will do baseline sitting pulmonary testing. Experimental order is balanced to avoid any training effects. Choice of sequence will be by random selection of envelope.
Methods Once consented, included subjects will do baseline sitting measurement of FEV1 and FVC which will give FEV1/FVC. Each subject will then be secured in a Ferno-Washington Model 71 litter wearing their own type 2 or 3 harness, or in a UL tested CMC ATOM Global Harness (California Mountain Corporation, Santa Barbara, CA) meeting ANSI Z359.11-2014 and NFPA 1983-2017 standards, if they don't have their own. The person will be secured with double Vs from the litter sides to the harness and footloops supporting them so their weight is on their feet and only minimally on the harness (if vertical). This process is consistent with industry standards for securing a patient in the litter and follows the specific model of the National Cave Rescue Commission.3 See figure 1 Prior to being secured in the litter the patient will do sitting baseline FEV1 and FVC with an NDDD spirograph. Once there is baseline data the subject will be secured in the litter. The investigators will then repeat spirometry, pulse, and blood pressure in a horizontal position (see figure 2), in a vertical position (see figure 3), and pitched slightly forward in a position that results from a Pike and Pivot rigging for raising up past a difficult cliff edge (see figure 4). The subject will get a rest period in their preferred position until pulse returns to within 5 beats of baseline.
Litter suspension will be with a four-legged litter spider when horizontal, with a high bridle tied directly to the litter head for the full vertical position, and from a low bridle in Pike-and-Pivot formation when pitched forward. The litter will be lifted into position with a 3:1 mechanical advantage system tied to an anchor. No matter the position, the lowest point of the litter will be no more than 6 inches off of the ground. The system will be configured for immediate lower for any expressed concern. The PI (RM) is a technical rescue instructor for the National Cave Rescue Commission and Assistant Training Officer-Technical Rescue for Fresno County search and rescue. The Co-PIs (SS and SD) are on the rope team of Fresno County search and rescue. Each is well versed in rope systems, anchor selection, and patient packaging.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Fresno, California, United States, 93701
- UCSF Fresno
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 130-310 pounds
Exclusion Criteria:
- Significant cardiac or pulmonary diseae
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Flat
Secured in a flat litter
|
Testing basic pulmonary function in three positions in a rescue litter, compared to sitting baseline
|
|
Active Comparator: Vertical
Secured in a vertical litter
|
Testing basic pulmonary function in three positions in a rescue litter, compared to sitting baseline
|
|
Active Comparator: Pitched forward
Secured in a litter leaning forward
|
Testing basic pulmonary function in three positions in a rescue litter, compared to sitting baseline
|
|
Placebo Comparator: Baseline
Sitting baseline pulmonary function
|
Testing basic pulmonary function in three positions in a rescue litter, compared to sitting baseline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Vital Capacity
Time Frame: Immediately
|
Measurable lung volume on expiration
|
Immediately
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FEV1
Time Frame: Immediately
|
Air volume exhaled in 1 second
|
Immediately
|
Collaborators and Investigators
Investigators
- Principal Investigator: Roger B Mortimer, MD, UCSF - Fresno
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 25-45106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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