Recruiting

Sedation Interruption

Sponsor:

Davinia Withington

Code:

NCT02426320

Conditions

Daily Sedative Interruption

Sedation Strategies

Sedation Protocols

Mechanical Ventilation

Sedation

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Sedation Interruption Protocol

Standard Sedation Protocol

Study Details

Brief 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.

Conditions

Daily Sedative Interruption

Sedation Strategies

Sedation Protocols

Mechanical Ventilation

Sedation

Study ID

NCT02426320

Start date

Apr, 2015

Status verified date

Apr, 2015

Completion date

Jun, 2015

Anticipated

Primary completion date

Apr, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Sedation Interruption Protocol + standard sedation protocol

Nurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia

active comparator: Standard sedation protocol

Nurse directed protocol for administering sedation and/or analgesia.

Interventions

Sedation Interruption Protocol

Standard Sedation Protocol

Primary outcome measure

  • Recruitment rate [ Time Frame: At 30 days ]
  • 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 ]

Central Contacts and Locations

Central contacts

Yasser Kazzaz, MBBS, FRCPC, FAAP

6479892770yasser.md@gmail.com

Davinia Withington, BM FRCA MRCP

davinia.withington@mcgill.ca

Locations

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H3H 1P3

More Information

Sponsor

Davinia Withington

Last update posted

Apr 24, 2015

Last verified

Apr, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Davinia Withington on 2015-04-24.