The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.

Study Overview
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Brief Summary
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Tracheostomized patients in the ICU can have excessive tracheal secretions due to various causes as hyperactive airway, irritation of the mucus producing cells and inhibition of the ciliary functions. Excessive secretions will necessitate frequent suctions which carries the risk of tracheostomy tube obstruction if not managed properly. Excessive tracheal secretions may prolong the ICU stay, increase the nurses workload and increase patients morbidity and mortality. This clinical trial hypothesizes that the use of glycopyrrolate may decrease the tracheal secretions and hence avoid such complications.

Detailed Description
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Patients fulfilling the inclusion criteria will be randomly assigned into one of 2 groups: Group G (Intervention group): Patients will receive Glycopyrrolate 0.2 mg IV every 8 hours. Group C (Control group): Patients will receive 2 mL Normal saline every 8 hours. Both injections will be labelled as drug A and drug B in the satellite pharmacy . Both the attending physician, nurse and data collector will be blinded to the injection given. Measurements data will be collected and recorded daily in the pre-prepared CRF during the study period.

Official Title
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The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.

Conditions
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Effect of Drugs

Intervention / Treatment
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* Drug: Glycopyrrolate 0.2 MG
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients above 18 years old. Patients who are admitted to ICU for more than 72 hours. Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours. Exclusion Criteria: Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate. Patients who have known sensitivity to Glycopyrrolate. Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation. Patients with mitral stenosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention group<br>receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily . | Drug: Glycopyrrolate 0.2 MG<br>* injections<br>* Other names: Glycopyrronium Injection;|
| Placebo Comparator: placebo group<br>receive normal saline 2 ml IV every 8 hours daily . | Drug: normal saline<br>* normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of suctions per day | Number of suctions per day | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of ICU days | the total days the patient will spend in ICU | 90 days | 
| Fio2 | Fio2 on mechanical ventilation every 4 hours daily | 6 days | 
| Mean airway pressure | Mean airway pressure will be recorded every 4 hours on the mechanical ventilator | 6 days | 
| Positive end expiatory pressure PEEP | PEEP will be recorded every 4 hours on the mechanical ventilator | 6 days | 
| The duration of mechanical ventilation days | Total days spent on mechanical ventilation | 90 days | 
| Side effects of Glycopyrrolate | Episodes of tachycardia if heart rate reach 120 beats / minute | 6 days | 
| Fluid intake | Fluid balance calculated daily | 6 days | 
| Total leukocyte count | Total leukocyte count daily | 6 days |