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Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

Primary Purpose

Respiratory Insufficiency, Respiration, Artificial, Conscious Sedation

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

remifentanil

placebo

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency, Respiration, Artificial, Remifentanil, Respiratory Mechanics, Work of Breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

respiratory rate/tidal volume

pressure-time product

Secondary Outcome Measures

double product of respiratory system

dynamic intrinsic PEEP

adverse events

arterial pH

level of sedation (RASS)

Full Information

NCT ID

NCT00665119

First Posted

April 18, 2008

Last Updated

December 17, 2008

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

1. Study Identification

Unique Protocol Identification Number

NCT00665119

Brief Title

Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

Official Title

Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Insufficiency, Respiration, Artificial, Conscious Sedation

Keywords

Respiratory Insufficiency, Respiration, Artificial, Remifentanil, Respiratory Mechanics, Work of Breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

remifentanil

Intervention Description

0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

NaCl 0.9 %

Primary Outcome Measure Information:

Title

respiratory rate/tidal volume

Time Frame

before and after remifentanil infusion; before and after placebo infusion.

Title

pressure-time product

Time Frame

before and after remifentanil infusion; before and after placebo infusion.

Secondary Outcome Measure Information:

Title

double product of respiratory system

Time Frame

before and after remifentanil infusion; before and after placebo infusion.

Title

dynamic intrinsic PEEP

Time Frame

before and after remifentanil infusion; before and after placebo infusion.

Title

adverse events

Time Frame

during all the study period

Title

arterial pH

Time Frame

before and after remifentanil infusion; before and after placebo infusion.

Title

level of sedation (RASS)

Time Frame

before and after remifentanil infusion; before and after placebo infusion.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Natalini, MD

Organizational Affiliation

Fondazione Poliambulanza Istituto Ospedaliero

Official's Role

Principal Investigator

Facility Information:

Facility Name

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

City

Brescia

ZIP/Postal Code

25124

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

21333087

Citation

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.

Results Reference

derived

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Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

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