Pilot Study for Sedation Interruption in Children

Mechanical Ventilation Clinical Trial

Official title:

Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02426320
• Other study ID #: 14-011-PED
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2015
• Last updated: April 23, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: McGill University Health Center
• Contact: Yasser Kazzaz, MBBS, FRCPC, FAAP
• Phone: 6479892770
• Email: yasser.md[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Ministère santé et services sociaux du Québec
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Daily Sedative Interruption
• Mechanical Ventilation
• Sedation
• Sedation Protocols
• Sedation Strategies

Intervention

Other:
• Sedation Interruption Protocol

• Standard Sedation Protocol

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Davinia Withington

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Anifantaki 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. — View Citation

Girard 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. — View Citation

Gupta 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. Erratum in: Pediatr Crit Care Med. 2012 May;13(3):373. Muralindharan, Jayashree [corrected to Jayashree, Muralindharan]. — View Citation

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. — View Citation

Mehta 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, Hébert 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. Erratum in: JAMA. 2013 Jan 16;309(3):237. — View Citation

Schweickert 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 30 days	No
Primary	Adherence Rate		At 30 days	No
Primary	Reasons for non-participation		At 30 days	No
Primary	Duration of mechanical ventilation in hours.	Total number of hours between the moment patient was intubated to the moment of extubation.	intraoperative	No