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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Active Comparator | receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily . |
|
| placebo group | Placebo Comparator | receive normal saline 2 ml IV every 8 hours daily . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrrolate 0.2 MG | Drug | injections |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of suctions per day | Number of suctions per day | 6 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Abosamak, MD | Contact | 00966599056616 | SAMAKAWY10@YAHOO.COM | |
| Mahmoud Fawzi, MD | Contact | 00966561339935 | mfawzi9966@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed Abosamak, MD | health care provider | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Security Forces Hospital | Riyadh | Saudi Arabia |
Data sharing will be participated after clinical trial registration complete.
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| normal saline | Drug | normal saline |
|
| 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 |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |