Effect of Drugs
Conditions
Brief summary
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
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.
Interventions
DRUGGlycopyrrolate 0.2 MG
injections
DRUGnormal saline
normal saline
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients above 18 years old. 2. Patients who are admitted to ICU for more than 72 hours. 3. Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours.
Exclusion criteria
1. Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate. 2. Patients who have known sensitivity to Glycopyrrolate. 3. Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation. 4. Patients with mitral stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of suctions per day | 6 days | Number of suctions per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fio2 | 6 days | Fio2 on mechanical ventilation every 4 hours daily |
| Mean airway pressure | 6 days | Mean airway pressure will be recorded every 4 hours on the mechanical ventilator |
| Positive end expiatory pressure PEEP | 6 days | PEEP will be recorded every 4 hours on the mechanical ventilator |
| The duration of ICU days | 90 days | the total days the patient will spend in ICU |
| Side effects of Glycopyrrolate | 6 days | Episodes of tachycardia if heart rate reach 120 beats / minute |
| Fluid intake | 6 days | Fluid balance calculated daily |
| Total leukocyte count | 6 days | Total leukocyte count daily |
| The duration of mechanical ventilation days | 90 days | Total days spent on mechanical ventilation |
Countries
Saudi Arabia
Contacts
Primary ContactMohammed Abosamak, MD
Backup ContactMahmoud Fawzi, MD
Outcome results
None listed