Abstract
Study design:
Prospective, randomized, controlled parallel group trial with single-blinded data analysis.
Objectives:
To determine the safety and efficacy of higher (20 ml kg−1 ideal body weight (IBW)) vs standard (10 ml kg−1 IBW) tidal volumes (Vt) for patients with sub-acute traumatic tetraplegia during ventilator weaning using a 14-day (minimum) weaning protocol.
Setting:
United States regional spinal cord injury treatment center.
Methods:
Thirty-three ventilator requiring inpatients were randomized to either the higher (Group 1) or the standard (Group 2) Vt protocol. Initially, all patients were ventilated at 10 ml kg−1 IBW Vt and 5 cm H2O of PEEP for 72 h. For Group 1, Vt was raised 100 ml kg−1 until reaching target Vt of 20 ml kg−1 IBW. Group 2 was maintained at Vt of 10 ml kg−1 IBW. Plateau pressures were kept at or below 30 cm H2O. Safety outcomes included incidence of adverse events.
Results:
Because of smaller than expected enrollment, evaluation of efficacy was not possible. Therefore, we report the safety outcomes of 33 study participants. The 16 patients in Group 1 and 17 patients in Group 2 were demographically similar at baseline, except for age. The average age was 39.3 years in Group 1 and 27.2 years in Group 2, (P=0.002). There was no difference in median days to wean: 14.5 days in Group 1 and 14 days in Group 2. The incidence of adverse pulmonary events was similar between groups.
Conclusion:
Higher tidal volumes can be safely utilized during weaning of patients with tetraplegia from mechanical ventilation using a 14-day weaning protocol.
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Acknowledgements
We thank the patients who volunteered to participate in this research. Gale Whiteneck, of the Craig Hospital Research Department participated in the conceptualization of the study design. Cate McGraw and Kelly Mowrey were actively involved in patient care and implementation of the research protocol. Matthew Fleishman, independently and blindly interpreted the chest radiographs. This research was supported by funding from the National Institute on Disability and Rehabilitation Research (NIDRR). The opinions here are those of the grantee and do not necessarily reflect those of the U.S. Department of Education, grant number H133N00006.
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Fenton, J., Warner, M., Lammertse, D. et al. A comparison of high vs standard tidal volumes in ventilator weaning for individuals with sub-acute spinal cord injuries: a site-specific randomized clinical trial. Spinal Cord 54, 234–238 (2016). https://doi.org/10.1038/sc.2015.145
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DOI: https://doi.org/10.1038/sc.2015.145
