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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2021-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Swallowing Rehabilitation of Dysphagic Tracheostomized Patients Under Mechanical Ventilation at ICU

NCT01496924

Dysphagia

UNKNOWN PHASE2

Effect of Parallel Oxygen Delivery Through a Tracheal Gas Insufflation (TGI) and a T-piece, on Blood Gases and Respiratory Rate, in ICU Tracheostomized Patients

NCT03040297

Resp Gas Exchange Disorder Nos

COMPLETED NA

the Effect of Adult Intubated Patient Clinical Pathway on Post-extubation Complications Prevention

NCT07081399

Dysphagia Dysphagia Rehabilitation

RECRUITING EARLY_PHASE1

Post -Extubation Respiratory Failure

NCT04441736

Respiratory Insufficiency

COMPLETED NA

Comparison of Traditional Dysphagia Therapy and Developed Protocol for Dysphagia Patients in Intensive Care Unit

NCT07005427

Dysphagia

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Effect of Drugs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention group

receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily .

Group Type ACTIVE_COMPARATOR

Glycopyrrolate 0.2 MG

Intervention Type DRUG

injections

placebo group

receive normal saline 2 ml IV every 8 hours daily .

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

normal saline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glycopyrrolate 0.2 MG

injections

Intervention Type DRUG

normal saline

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Glycopyrronium Injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No