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The clinical characteristics of the PGE,-treated and control patients are presented in Table 1. There were no differences in the age, sex, APACHE II or ARDS scores, or cause of ARDS between PGE ^treated and control patients. The most common causes of ARDS in PGE,-treated and control patients were sepsis, aspiration syndrome, and multiple trauma.

Selected hemodynamic and laboratory variables at entry (day 0) of PGE,-treated and control patients are shown in Table 2. Heart rate was greater in control than in PGE,-treated patients. There were no other significant differences between PGE,-treated and con­trol patients at entry.

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Measurements

Right atrial, pulmonary arterial, and pulmonary arterial occlusion pressures were measured at the end of expiration referenced to atmospheric pressure using flow-directed pulmonary arterial cath­eters (Gould Inc), transducers (Gould Inc), and bedside monitors. Cardiac output was measured in triplicate using the thermodilution technique (Gould Inc), with room-temperature 5 percent dextrose in water. Systemic arterial pressure was measured using radial or femoral arterial catheters. Specimens of mixed venous and arterial blood were obtained for measurement of Sa0₂, Pa0₂, Sv0₂, Pv0₂, and arterial bilirubin and creatinine concentrations. We calculated CI, SVRI, and PVRI using standard formulae. The CaO, and СЮ₂ were calculated from the following equations.

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This study was performed with approval of the St. Pauls Hospital Research and Ethics Committees, and informed consent was obtained from the next of kin of all PGE,-treated patients.

Selection of Patients

Patients in the ICU of St. Paul’s Hospital were included in the study (April 1985 to May 1986) if they had ARDS without significant renal or hepatic dysfunction. The ARDS was defined as acute respiratory failure with diffuse bilateral pulmonary infiltrates on the chest roentgenogram, mechanical ventilation for 24 hours with PEEP greater than 5 cm H₂0 with P^0₂ less than 90 mm Hg on FIo₂ of greater than 0.4 (PaO/FIo₂<225 mm Hg), and pulmonary capillary wedge pressure less than 18 mm Hg. Renal dysfunction was defined as a serum creatinine level greater than 3 mg/dl, and hepatic dysfunction was defined as a serum bilirubin level greater than 3 mg/dl. Two patients with Pneumocystis carinii pneumonia in association with AIDS were included (cases 7 and 8); however, following their inclusion, the sponsor decided that AIDS would be criterion for exclusion of subsequently enrolled patients. One patient (case 6) with hepatic failure (bilirubin level, 19.1 mg/dl) was entered before the exclusion criterion of hepatic dysfunction was established by the sponsor.

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Therapy for ARDS has been supportive because of the failure to find an agent or device which significantly reduces mortality. Prostaglandin E, has important vasodilating and anti-inflammatory actions which make it appealing for the treatment of patients with ARDS. Prostaglandin E, increases cardiac output and systemic oxygen delivery while reducing pulmo­nary artery pressure and vascular resistances. Infu­sion of an analog agent, prostacyclin (PGI₂), success­fully identified occult tissue hypoxia by increasing oxygen delivery in patients with acute respiratory failure who developed multiple-system organ failure and died. In a prospective, randomized, double-blind placebo-controlled trial in surgical patients, Holcroft et al noted a significant decrease in the 30-day mortality of patients with ARDS treated with PGE,. Unfortunately, the overall in-hospital mortality of all PGE,-treated patients was not significantly lower than the mortality of patients receiving placebo (p = 0.08).

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Most standard hospital volume respirators are de­signed to deliver and assess ventilation in a closed system, including tracheostomy or intubation tube cuff inflation. Only portable ventilators are currently adequate for TIPPV with cuffs deflated or removed. Further, most if not all current nursing and respiratory therapy school curricula emphasize the need for closed systems and do not present how to support ventilation with cuffless tubes, body ventilators, or by other noninvasive methods. As a result, following successful management of acute respiratory failure, many pa­tients are maintained with their cuffs unnecessarily inflated and forced to explore nonverbal means of communication despite the fact that the majority of patients with neuromuscular disease may be success­fully ventilated through cuffless tracheostomy tubes.

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Ninety-one of the 104 patients converted from TIPPV with an inflated cuff to either a deflated cuff (28 patients) or no cuff (63 patients). These patients remained dependent on TIPPV in this manner for an average of 4.2 years (range, one week to 29 years), including 23 patients for nine years or more. Ten of the remaining patients converted from TIPPV with inflated cuffs directly to noninvasive alternatives of ventilatory support and three patients continue to use TIPPV with their cuffs partially inflated. The most recent average VCs of these 104 patients was 529 ml (13 percent of predicted) sitting and 481 ml (12 percent of predicted) supine. Eighty-four of the 104 patients had a VC supine less than 20 percent of predicted normal with 13 patients having no measurable VC. All 91 patients were able to use inspiratory cycle speech with good volume while receiving TIPPV

Of the 91 patients receiving TIPPV with deflated cuffs or cuffless tubes, 14 who required only overnight aid were eventually converted to body ventilator support with Chest Shells or Pulmowraps. Thirty-four others were converted to daytime Pneumobelt use and noninvasive positive airway pressure ventilatory support (intermittent positive pressure ventilation [IPPV] via the mouth and/or nose) up to 24 h a day. Five were eventually weaned from support and seven were unavailable for follow-up at the time of the study. Nineteen of the above patients are dead.

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