- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786617
The Efficacy of Nurse-driven, Protocol Guided Ventilator Weaning in a Medical-Surgical Intensive Care Unit (ICU)
The Efficacy of Nurse-driven, Protocol Guided Ventilator Weaning in a Medical-Surgical ICU
- Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will have a mean length of stay on ventilator at least one day shorter than patients weaned by physician-initiated, non-protocol methods
- Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol will have al least similar Ventilator, ICU, and Hospital Length Of Stay (LOS) compared to patients weaned by physician-initiated, non-protocol method
- Nurse-driven ventilator weaning protocol is well accepted by other services: physicians, nurses, and respiratory therapists.
Study Overview
Status
Conditions
Detailed Description
Ventilatory support is one of the most common indications for admission to ICU (1).
The duration of mechanical ventilation is associated with several serious complications, increase mortality, prolong ICU stay, and increase hospital cost (7,8).
Traditionally, the process of ventilator weaning is initiated and carried out my physicians.
Recently, there have been few studies that supported the utility of protocol guided weaning algorithms. Its use have been associated with earlier initiation of weaning, leading to shorter ventilator time, and a trend for shorter ICU length-of-stay and lower hospital costs (1,2,4,9) Several studies have also shown the relative safety of utilizing nursing (3) and RT staff alone or in cooperation with medical staff in the weaning of patients from mechanical ventilation (1,2,6).
We recently developed a nurse-driven ventilator weaning protocol for all ICUs at St. Luke's and Roosevelt hospitals. The protocol was approved by the Critical Care Committee and is implemented as of May 2007. All ICU nurses, respiratory therapists, and ICU physicians have been educated on this protocol We plan to prospectively collect data to look at length of stay on mechanical ventilation in patients weaned by nurse-driven ventilator weaning protocol. We plan to compare such data to retrospectively collected ventilator LOS data in patients weaned by physician-initiated ventilator weaning method.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Receiving MV for at least 24 hours in the ICU
- Meeting established protocol criteria for a vent wean trial
Exclusion Criteria:
- Patients in whom MV was actively withdrawn for terminal wean
- Brain dead patients on MV
- Age <18 years old
- Transfers from other hospitals or health care facility who were ventilator dependent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Nurse-driven
Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol
|
|
Physician-initated
Mechanically ventilated patients weaned by physician-initiated, non-protocol methods
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Average Length of Stay on Ventilator
Time Frame: up to 5 months
|
up to 5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ICU mortality
Time Frame: up to 5 months
|
up to 5 months
|
|
Hospital mortality
Time Frame: up to 5 months
|
up to 5 months
|
|
Treatment intensity and resource allocation: Cost of ICU care per year
Time Frame: up to 5 months
|
up to 5 months
|
|
Level of acceptance of nurse-driven vent weaning protocol
Time Frame: up to 5 months
|
up to 5 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.
- Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
- Kollef MH, Shapiro SD, Silver P, St John RE, Prentice D, Sauer S, Ahrens TS, Shannon W, Baker-Clinkscale D. A randomized, controlled trial of protocol-directed versus physician-directed weaning from mechanical ventilation. Crit Care Med. 1997 Apr;25(4):567-74. doi: 10.1097/00003246-199704000-00004.
- Thorens JB, Kaelin RM, Jolliet P, Chevrolet JC. Influence of the quality of nursing on the duration of weaning from mechanical ventilation in patients with chronic obstructive pulmonary disease. Crit Care Med. 1995 Nov;23(11):1807-15. doi: 10.1097/00003246-199511000-00004.
- Ramachandran V, Grap MJ, Sessler CN. Protocol-directed weaning: a process of continuous performance improvement. Crit Care. 2005 Apr;9(2):138-40. doi: 10.1186/cc3053. Epub 2005 Jan 28.
- Marelich GP, Murin S, Battistella F, Inciardi J, Vierra T, Roby M. Protocol weaning of mechanical ventilation in medical and surgical patients by respiratory care practitioners and nurses: effect on weaning time and incidence of ventilator-associated pneumonia. Chest. 2000 Aug;118(2):459-67. doi: 10.1378/chest.118.2.459.
- Salam A, Tilluckdharry L, Amoateng-Adjepong Y, Manthous CA. Neurologic status, cough, secretions and extubation outcomes. Intensive Care Med. 2004 Jul;30(7):1334-9. doi: 10.1007/s00134-004-2231-7. Epub 2004 Mar 4.
- Dries DJ, McGonigal MD, Malian MS, Bor BJ, Sullivan C. Protocol-driven ventilator weaning reduces use of mechanical ventilation, rate of early reintubation, and ventilator-associated pneumonia. J Trauma. 2004 May;56(5):943-51; discussion 951-2. doi: 10.1097/01.ta.0000124462.61495.45.
- Wood G, MacLeod B, Moffatt S. Weaning from mechanical ventilation: physician-directed vs a respiratory-therapist-directed protocol. Respir Care. 1995 Mar;40(3):219-24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 07-122
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