Litter Packaging in the Lateral Position: Effects of Position and Vacuum Mattress Packaging on Pulmonary Function
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Roger B Mortimer, MD
- 電話番号:15594996450
- メール:roger.mortimer@ucsf.edu
研究連絡先のバックアップ
- 名前:Michelle Horwege, MSHCA
- 電話番号:5594996450
- メール:michelle.horwege@ucsf.edu
研究場所
-
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California
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Fresno、California、アメリカ、93701
- University of California, San Francisco
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:なし
- 介入モデル:順次割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Comparison of pulmonary function by litter packaging
Order of packaging
|
Different packaging paradigms in a rescue litter done in a random order.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Forced Vital Capacity
時間枠:1 hour
|
Forced Vital Capacity
|
1 hour
|
|
1 second forced vital capacity
時間枠:1 hour
|
1 second forced vital capacity
|
1 hour
|
協力者と研究者
捜査官
- 主任研究者:Roger B Mortimer, MD、UCSF - Fresno
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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