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Biomedical subjects

Jack Clausen

Publications and source records attributed to Jack Clausen.

3 recordsLinked to original sources

Weight force during prone restraint and respiratory function.

Prone maximal restraint position (PMRP, also known as hogtie or hobble) is often used by law enforcement and prehospital personnel on violent combative individuals in the field setting. Weight force is often applied to the restrained individual's back and torso during the restraint process. We sought to determine the effect of 25 and 50 lbs weight force on respiratory function in human subject volunteers placed in the PMRP. We performed a randomized, cross-over, controlled trial on 10 subjects placed in 4 positions for 5 minutes each: sitting, PRMP, PRMP with 25 lbs weight force (PMRP+25), and PRMP with 50 lbs weight force placed on the back (PMRP+50). We measure pulse oximetry, end-tidal CO2 levels, and forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1). FVC and FEV1 were significantly lower in all restraint positions compared with sitting but not significantly different between restraint positions with and without weight force. Moreover, mean oxygen saturation levels were above 95% and mean end-tidal CO2 levels were below 45 mm Hg for all positions. We conclude that PMRP with and without 25 and 50 lbs of weight force resulted in a restrictive pulmonary function pattern but no evidence of hypoxia or hypoventilation.

Adult↗

Biochemical efficacy and safety of a new pooled human plasma alpha(1)-antitrypsin, Respitin.

BACKGROUND: Augmentation therapy with pooled human plasma-derived alpha(1)-antitrypsin (AAT) has been shown to have biochemical efficacy in restoring serum AAT levels above the protective threshold. Also, clinical efficacy has been suggested. OBJECTIVE: To evaluate the bioequivalence of a new solvent detergent-treated preparation of pooled human plasma-derived AAT (proposed name Respitin; Alpha Therapeutic Corporation; Los Angeles, CA) to the commercially available preparation (Prolastin; Bayer Corporation; West Haven, CT), we conducted a randomized controlled trial. METHODS: Eligible subjects were adults (> 18 years of age) who had never smoked or were ex-smokers, had severe deficiency of AAT, and had fixed airflow obstruction (ie, postbroncholdilator FEV(1) of 30 to 80% of predicted values and/or diffusing capacity of the lung for carbon monoxide [DLCO] of < 70% of predicted values with evidence of emphysema on a CT scan). Of the 28 subjects recruited, 26 completed the 12-week comparison. Participants were randomized to receive Respitin (60 mg/kg once weekly; 14 subjects) or Prolastin (60 mg/kg once weekly; 14 subjects), and recipients of Prolastin then crossed over to receive Respitin thereafter for the 24-week duration of the study. RESULTS: The primary efficacy criteria were satisfied for equivalence to comparator (ie, the ratio of mean trough serum levels for Respitin/Prolastin at weeks 8 to 11 exceeded the efficacy criterion [0.905; p = 0.0206] as did the slope of the mean trough level over weeks 11 to 23 [-0.003 micromol per week]). In Respitin recipients, the trough serum antineutrophil elastase capacity at week 7 and at weeks 8 to 11 was also equivalent to the comparator, as was the rise in AAT levels in epithelial lining fluid from baseline to week 7. The levels of urinary elastin degradation products showed little appreciable change for > 24 weeks, and no difference between compared groups was shown through week 12. Adverse events were similarly infrequent in compared groups. Finally, neither spirometry measurements nor DLCO showed a significant change through 24 weeks. CONCLUSIONS: We conclude that this new solvent detergent-treated pooled human plasma-derived AAT (Respitin) demonstrates biochemical equivalence to Prolastin and that this new drug is well-tolerated.

Adult↗

The effect of oleoresin capsicum "pepper" spray inhalation on respiratory function.

We performed a randomized, cross-over controlled trial to assess the effect of Oleoresin capsicum (OC) spray inhalation on respiratory function by itself and combined with restraint. Thirty-five subjects were exposed to OC or placebo spray, followed by 10 min of sitting or prone maximal restraint position (PMRP). Spirometry, oximetry, and end-tidal CO2 levels were collected at baseline and throughout the 10 min. Data were compared between groups (ANOVA) and with predefined normal values. In the sitting position, OC did not result in any significant changes in mean percent predicted forced vital capacity (%predFVC), percent predicted forced expiratory volume in 1 s (%predFEV1), oxygen, or CO2 levels. In PMRP, mean %predFVC and %predFEV1 fell 14.4 and 16.5% for placebo and 16.2 and 19.1% for OC, but were not significantly different by exposure. There was no evidence of hypoxemia or hypercapnia in either groups. OC exposure did not result in abnormal spirometry, hypoxemia, or hypoventilation when compared to placebo in either sitting or PMRP.

Adult↗