Lead Center:Northern New Jersey Spinal Cord Injury System
Principal Investigator Name:Steven Kirshblum, MD and John Bach, MD
Principal Investigator Email:email@example.com
Target Population(s):Persons with spinal cord injury
Objective: To determine the efficacy of a treatment utilizing oximetry to monitor oxygen saturation with manual and mechanical assisted cough techniques in preventing community acquired pneumonia (CAP) and other severe respiratory complications (respiratory tract infections (RTI) that require antibiotics or atelectasis) in persons with chronic spinal cord injury (SCI). Hypothesis: We hypothesize that oximetry with manual and mechanical assisted cough (O-MMAC) will be more effective than oximetry with incentive spirometry (O-SPIR) in preventing severe respiratory complications and hospitalizations for respiratory infections in persons with SCI. Design: Prospective, single-blind, randomized controlled trial Participants: One hundred sixty persons with chronic SCI (> 6 months) who have an ineffective cough (cough peak flows [CPF] < 300 L/min). Intervention: Participants will be randomly assigned to either a treatment group using oximetry with manual and mechanical assisted cough (O-MMAC) or an active control group using an oximetry with incentive spirometry (O-SPIR). Participants in both groups will receive pneumococcal and influenza vaccines as recommended by current American Thoracic Society guidelines. Main Outcome Measures: The primary efficacy endpoints will be 1) reductions in episodes of CAP and related severe respiratory complications (RTI requiring antibiotics or atelectasis [lung collapse]) and 2) reductions in hospitalizations due to a primary diagnosis of a respiratory complications. Secondary measures will include duration of illness and hospitalization and indicators of the impact of these respiratory complications on quality of life (QOL) and participation. Pulmonary function tests (CPF, vital capacity [VC], and maximum insufflation capacity [MIC]), will be performed at baseline, 6, 12, 24, and 36 months. A baseline chest roentgenogram will be obtained unless one was previously taken six months prior to entry into the study and is available for review. Expected results: We expect that the improved at-home respiratory management protocol using O-MMAC techniques will be significantly more effective than the O-SPIR group and prevent the majority of cases of CAP and hospitalizations due to respiratory complications among high risk persons with SCI. The study should lead to improved respiratory management guidelines and more effective care for persons with SCI.