Effect of Daily Nicotine Patch Application on Mechanical Ventilation Weaning in Smoking Patients

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

Nicotine patches are frequently used in smoking patients during their stay in the ICU in order to avoid tobacco's weaning symptoms which are likely to interfere with mechanical ventilation weaning.

The aim of this study (NICOREA study) is to determine if a difference exists on the duration of mechanical ventilation once patients receive or not a nicotine substitute.

It had two arms (groups): Nicotine (active comparator) and Placebo (placebo comparator).

One or two patch(es) with placebo.

The registry classes the interventions as drug.

More on the Plan

Six hundred mechanically ventilated patients are going to be enrolled to receive nicotine or placebo during a 24 month period in 14 centers in France.

Who Took Part

Enrollment: 600 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 18 et 80 yrs. SOFA score below or equal to 16 at randomization time. Patient expected to be mechanically ventilated for at least 24hrs. Patient known to be usually smoking more than 10 cigarettes per day according to her/him or to a next of kin. Consent obtained from the patient or a next of kin.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: patients having been in the icu for more than 72 hours or mechanically ventilated since more than 48 hours; isolated brain trauma; patients weaned from tobacco since more than 21 days.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-01 with completion listed for 2012-02.

It ran at 1 site in France.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Length of mechanical ventilation expressed in hours (time frame: 48 hours after extubation).

It also tracked 10 secondary outcomes, for example Length of stay in the ICU expressed in day(s), Number of failure of mechanical ventilation weaning, Incidence of score above +1 of the RASS scale measured every 4 hours, Number of days with delirium assessed by the CAM-ICU score, Number of hours under sedation below RASS -4, between -3,-2, -2,+1 indexed by the overall duration of sedation and Number of self-extubation(s).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 600 people.

With 600 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.