Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00665119
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Fondazione Poliambulanza Istituto Ospedaliero

Tracking Information
First Submitted Date  ICMJE April 18, 2008
First Posted Date  ICMJE April 23, 2008
Last Update Posted Date December 18, 2008
Study Start Date  ICMJE April 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
  • respiratory rate/tidal volume [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
  • pressure-time product [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
  • double product of respiratory system [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
  • dynamic intrinsic PEEP [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
  • adverse events [ Time Frame: during all the study period ]
  • arterial pH [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
  • level of sedation (RASS) [ Time Frame: before and after remifentanil infusion; before and after placebo infusion. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients
Official Title  ICMJE Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.
Brief Summary Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high respiratory rate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiratory Insufficiency
  • Respiration, Artificial
  • Conscious Sedation
Intervention  ICMJE
  • Drug: remifentanil
    0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion
  • Drug: placebo
    NaCl 0.9 %
Study Arms  ICMJE Experimental: treatment
Any patient alternatively receive both remifentanil and isotonic saline (placebo)infusion. The order of infusion is randomized. An interval of 30 minutes is planned between the two infusions.
Interventions:
  • Drug: remifentanil
  • Drug: placebo
Publications * Natalini G, Di Maio A, Rosano A, Ferretti P, Bertelli M, Bernardini A. Remifentanil improves breathing pattern and reduces inspiratory workload in tachypneic patients. Respir Care. 2011 Jun;56(6):827-33. doi: 10.4187/respcare.01014. Epub 2011 Feb 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2008)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • pressure support ventilation or CPAP
  • respiratory rate > 35.min-1
  • respiratory rate/tidal volume > 105

Exclusion Criteria:

  • vasoactive agents (dopamine lower than 5 mcg.kg-1.min-1 is not considered as vasoactive agent)
  • body temperature > 38 °C
  • Glasgow Coma Scale < 9
  • FIO2 > 0.6
  • PEEP > 10 cmH2O
  • pH < 7.30
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00665119
Other Study ID Numbers  ICMJE FP-TIP-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Natalini Giuseppe, FPoliambulanza
Study Sponsor  ICMJE Fondazione Poliambulanza Istituto Ospedaliero
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giuseppe Natalini, MD Fondazione Poliambulanza Istituto Ospedaliero
PRS Account Fondazione Poliambulanza Istituto Ospedaliero
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP