Vent Weaning in Medical- Surgical ICUsNCT00786617
The Efficacy of Nurse-driven, Protocol Guided Ventilator Weaning in a Medical-Surgical Intensive Care Unit (ICU)
An observational study of Vent Weaning in Medical- Surgical ICUs, run by St. Luke's-Roosevelt Hospital Center.
Trial summary
1. 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 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vent Weaning in Medical- Surgical ICUs
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically Ventilated Patients in Medical-Surgical ICU
Who may be able to join
- Receiving MV for at least 24 hours in the ICU
- Meeting established protocol criteria for a vent wean trial
Who cannot join
- Patients in whom MV was actively withdrawn for terminal wean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
About this study
Official title: 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.
Read the 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.
- Conditions
- Vent Weaning in Medical- Surgical ICUs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Average Length of Stay on Ventilator
Measured: up to 5 months
Secondary outcomes (4)
ICU mortality
Measured: up to 5 months
Hospital mortality
Measured: up to 5 months
Treatment intensity and resource allocation: Cost of ICU care per year
Measured: up to 5 months
Level of acceptance of nurse-driven vent weaning protocol
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Vent Weaning in Medical- Surgical ICUsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Khouli, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786617
- Sponsor's protocol ID
- 07-122
- Status last verified
- Mar 2015
- First submitted
- 5 Nov 2008
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9142019Thorens 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.
PubMed 7587255Ramachandran 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.
PubMed 15774063Ely 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.
PubMed 8948561Marelich 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.
PubMed 10936141Salam 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.
PubMed 14999444Kress 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.
PubMed 10816184Dries 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.
PubMed 15179231Wood 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.
PubMed 10141679
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Nurse-driven, Protocol Guided Ventilator Weaning in a Medical-Surgical ICU
- ClinicalTrials.gov ID
- NCT00786617
- Acronym / sponsor ID
- 07-122
- Conditions
- Vent Weaning in Medical- Surgical ICUs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-driven | – | –Mechanically ventilated patients weaned by nurse-driven ventilator weaning protocol |
| Physician-initated | – | –Mechanically ventilated patients weaned by physician-initiated, non-protocol methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically Ventilated Patients in Medical-Surgical ICU
Key inclusion criteria (2 listed)
- Receiving MV for at least 24 hours in the ICU
- Meeting established protocol criteria for a vent wean trial
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average Length of Stay on Ventilator
Time frame: up to 5 months
4 secondary outcomes
ICU mortality
Time frame: up to 5 months
Hospital mortality
Time frame: up to 5 months
Treatment intensity and resource allocation: Cost of ICU care per year
Time frame: up to 5 months
Level of acceptance of nurse-driven vent weaning protocol
Time frame: up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Background: PubMed 9142019Kollef 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.
- Background: PubMed 7587255Thorens 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.
- Background: PubMed 15774063Ramachandran 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.
- Background: PubMed 8948561Ely 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.
- Background: PubMed 10936141Marelich 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.
- Background: PubMed 14999444Salam 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.
- Background: PubMed 10816184Kress 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.
- Background: PubMed 15179231Dries 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.
- Background: PubMed 10141679Wood 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Khouli, MD principal investigator
St. Luke's-Roosevelt Hospital Center
Questions about this trial
What is this clinical trial studying?
An observational study of Vent Weaning in Medical- Surgical ICUs, run by St. Luke's-Roosevelt Hospital Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Length of Stay on Ventilator (time frame: up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786617, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.