Daily Sedative InterruptionNCT02426320
Pilot Study for Sedation Interruption in Children
A study testing Sedation Interruption Protocol and Standard Sedation Protocol in people with Daily Sedative Interruption and Sedation Strategies, run by Davinia Withington at 1 site in Canada.
Trial summary
The purpose of this study is to estimate the hypothesized benefit of sedation interruption protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate recruitment rates, and adherence rates of such protocol. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Daily Sedative Interruption, Sedation Strategies, Sedation Protocols
- What is being tested?
- Sedation Interruption Protocol and Standard Sedation Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Jun 2015
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Intubated and mechanically ventilated patients due to respiratory failure of multiple etiologies or after major surgical procedures for more than 24 hours.
- Sedation managed by benzodiazepines and opioids infusions
Who cannot join
- If sedation is required as part of medical management (Pulmonary hypertension, Increase intracranial pressure, Seizures
- Trauma \& burn admissions
- Patients resuscitated from cardiac arrest
- Allergy to sedation (midazolam)
- Allergy to analgesia (fentanyl, morphine)
- Difficult airway including post-operative airway surgeries. (As deemed by ICU physician in charge)
Show all 13Show fewer
- High frequency oscillator
- Special gas as inhaled nitric oxide, or isoflurane.
- Chronic ventilatory support
- Neuromuscular diseases
- Corrected Gestational age less than 37 weeks.
- Patients not expected to survive to discharge as per attending physician.
- Palliative care patients.
Trial locations and contacts
1 site in 1 country.
Davinia Withington, BM FRCA MRCP contact
Canada1 site, 1 recruiting
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
About this study
Official title: Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study
The purpose of this study is to estimate the hypothesized benefit of sedation interruption protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate recruitment rates, and adherence rates of such protocol.
Read the detailed description
This is a prospective single-center, superiority, open randomized controlled trial comparing sedation interruption protocol and routine continuous sedation in mechanically ventilation (MV) children.
The study will be conducted in the twelve beds Pediatric Intensive Care Unit (PICU) at the Montreal Children's Hospital, a pediatric tertiary care and teaching hospital.
Patients will be enrolled prospectively within 24 hours of intubation and MV. After obtaining written consent patients will then be randomized to interrupted sedation or standard sedation protocol. The investigators will randomize using a computer-generated sequence of random numbers.
A Sedation protocol will be used for both groups to adjust continuous infusions of sedatives/analgesics to a targeted Comfort-Behavior scale. In the intervention group, sedation infusions will be interrupted daily at 8:00 AM, this interruption will be continued until the patient is under-sedated according to the Comfort Behavior scale goals or in the presence of symptoms of hemodynamic instability or respiratory distress. Then the patient will receive a bolus of sedation and the infusion will be restarted at a dose 50% less than the previous dose to return to the Comfort Score goal.
- Conditions
- Daily Sedative Interruption, Sedation Strategies, Sedation Protocols, Mechanical Ventilation, Sedation
- Being tested
- Sedation Interruption Protocol, Standard Sedation Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation Interruption ProtocolOther
Standard Sedation ProtocolOther
| Study group | Role | What they receive |
|---|---|---|
| Sedation Interruption Protocol + standard sedation protocol | Active comparator | Nurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia Receives: Other: Sedation Interruption Protocol |
| Standard sedation protocol | Active comparator | Nurse directed protocol for administering sedation and/or analgesia. Receives: Other: Standard Sedation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The number of eligible patients who provided informed consent to participate in the study divided by the total number of eligible patients who were asked for informed consent during the pilot study period over 1 year period.
Measured: At 30 days
Adherence Rate
Measured: At 30 days
Reasons for non-participation
Measured: At 30 days
Duration of mechanical ventilation in hours.
Total number of hours between the moment patient was intubated to the moment of extubation.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Daily Sedative InterruptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Davinia Withington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Davinia Withington, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Conall Francoeur, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreChristina Maratta, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMaryse Dagenais, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426320
- Sponsor's protocol ID
- 14-011-PED
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10816184Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.
PubMed 15187505Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
PubMed 18191684Anifantaki S, Prinianakis G, Vitsaksaki E, Katsouli V, Mari S, Symianakis A, Tassouli G, Tsaka E, Georgopoulos D. Daily interruption of sedative infusions in an adult medical-surgical intensive care unit: randomized controlled trial. J Adv Nurs. 2009 May;65(5):1054-60. doi: 10.1111/j.1365-2648.2009.04967.x.
PubMed 19399980Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872.
PubMed 23180503Gupta K, Gupta VK, Jayashree M, Singhi S. Randomized controlled trial of interrupted versus continuous sedative infusions in ventilated children. Pediatr Crit Care Med. 2012 Mar;13(2):131-5. doi: 10.1097/PCC.0b013e31820aba48.
PubMed 21283046
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02426320
- Acronym / sponsor ID
- 14-011-PED
- Conditions
- Daily Sedative Interruption, Sedation Strategies, Sedation Protocols, Mechanical Ventilation, Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Davinia WithingtonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 24 Apr 2015 (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.
The purpose of this study is to estimate the hypothesized benefit of sedation interruption protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate recruitment rates, and adherence rates of such protocol.
Detailed description
This is a prospective single-center, superiority, open randomized controlled trial comparing sedation interruption protocol and routine continuous sedation in mechanically ventilation (MV) children.
The study will be conducted in the twelve beds Pediatric Intensive Care Unit (PICU) at the Montreal Children's Hospital, a pediatric tertiary care and teaching hospital.
Patients will be enrolled prospectively within 24 hours of intubation and MV. After obtaining written consent patients will then be randomized to interrupted sedation or standard sedation protocol. The investigators will randomize using a computer-generated sequence of random numbers.
A Sedation protocol will be used for both groups to adjust continuous infusions of sedatives/analgesics to a targeted Comfort-Behavior scale. In the intervention group, sedation infusions will be interrupted daily at 8:00 AM, this interruption will be continued until the patient is under-sedated according to the Comfort Behavior scale goals or in the presence of symptoms of hemodynamic instability or respiratory distress. Then the patient will receive a bolus of sedation and the infusion will be restarted at a dose 50% less than the previous dose to return to the Comfort Score goal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation Interruption Protocol + standard sedation protocol | Active comparator | Other: Sedation Interruption ProtocolNurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia |
| Standard sedation protocol | Active comparator | Other: Standard Sedation ProtocolNurse directed protocol for administering sedation and/or analgesia. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Intubated and mechanically ventilated patients due to respiratory failure of multiple etiologies or after major surgical procedures for more than 24 hours.
- Sedation managed by benzodiazepines and opioids infusions
Key exclusion criteria (13 listed)
- If sedation is required as part of medical management (Pulmonary hypertension, Increase intracranial pressure, Seizures
- Trauma \& burn admissions
- Patients resuscitated from cardiac arrest
- Allergy to sedation (midazolam)
- Allergy to analgesia (fentanyl, morphine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation Interruption Protocol | Other | Sedation Interruption Protocol + standard sedation protocol |
| Standard Sedation Protocol | Other | Standard sedation protocol |
Primary outcome
Recruitment rate
Time frame: At 30 days
The number of eligible patients who provided informed consent to participate in the study divided by the total number of eligible patients who were asked for informed consent during the pilot study period over 1 year period.
Adherence Rate
Time frame: At 30 days
Reasons for non-participation
Time frame: At 30 days
Duration of mechanical ventilation in hours.
Time frame: intraoperative
Total number of hours between the moment patient was intubated to the moment of extubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- 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 15187505Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.
- Background: PubMed 18191684Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
- Background: PubMed 19399980Anifantaki S, Prinianakis G, Vitsaksaki E, Katsouli V, Mari S, Symianakis A, Tassouli G, Tsaka E, Georgopoulos D. Daily interruption of sedative infusions in an adult medical-surgical intensive care unit: randomized controlled trial. J Adv Nurs. 2009 May;65(5):1054-60. doi: 10.1111/j.1365-2648.2009.04967.x.
- Background: PubMed 23180503Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872.
- Background: PubMed 21283046Gupta K, Gupta VK, Jayashree M, Singhi S. Randomized controlled trial of interrupted versus continuous sedative infusions in ventilated children. Pediatr Crit Care Med. 2012 Mar;13(2):131-5. doi: 10.1097/PCC.0b013e31820aba48.
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.
Davinia Withington, BM FRCA MRCP contact
Conall Francoeur principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Christina Maratta principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Maryse Dagenais principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation Interruption Protocol and Standard Sedation Protocol in people with Daily Sedative Interruption and Sedation Strategies, run by Davinia Withington at 1 site in Canada.
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 13 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: status not confirmed, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasser Kazzaz, MBBS, FRCPC, FAAP (6479892770, yasser.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: At 30 days). The study lists 4 primary outcomes in all. 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 NCT02426320, which also lists 6 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 24 Apr 2015.