Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04061083
Other study ID # 118S409
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 16, 2019
Est. completion date December 1, 2019

Study information

Verified date February 2023
Source Afyonkarahisar Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents.


Description:

In the study, ET cuff pressure control will be provided with pilot balloon fingers (Control Group), intermittent with a manometer (Study Group 1) and continuously with a smart cuff manager (Study Group 2). To assess the effect of different ETT cuff pressure control on microaspiration of the stomach contents, the pepsin level will be measured during deep tracheal secretions. The samples will be examined in the first four hours after intubation, all secretions collected up to the 24th hour of intubation after first sample intake and all secretions collected between 24-48 hours after intubation. Pepsin level will be considered as positive for cut-off point. In addition, the effect of different ETT cuff pressures control on the incidence of VAP will be examined.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Volunteering of the patient or relatives who will participate in the study, - Patients who require mechanical ventilation support with endotracheal tube supply for 48 hours. Exclusion Criteria: - Patients who are contraindicated in giving a semi-fowler position, - Patients with enteral nutrition contraindications, - Patients connected to mechanical ventilators for more than 48 hours, - Patients with tracheostomy, - Patients admitted to ICU for gastroesophageal reflux disease, aspiration pneumonia or suspicion, - Nasal endotracheal intubation.

Study Design


Intervention

Device:
Smart Cuff Manager
Participant will be attached to the smart cuff manager within 4 hours after intubation. They will remain attached during the first 48 hours of intubation in the intensive care unit
Manometer
Participant will be attached to the manometer within 4 hours after intubation. They will assess 3 times per day during the first 48 hours of intubation in the intensive care unit

Locations

Country Name City State
Turkey Özlem SOYER Afyonkarahisar Center

Sponsors (3)

Lead Sponsor Collaborator
Afyonkarahisar Health Sciences University Afyonkarahisar Health Sciences University Hospital, The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microaspiration of Gastric Contents The unintentional aspiration of very small amounts of gastric contents From randomisation to 48 hours after intubation
See also
  Status Clinical Trial Phase
Recruiting NCT05030337 - Optimising Ventilation in Preterms With Closed-loop Oxygen Control N/A
Completed NCT05144607 - Impact of Inspiratory Muscle Pressure Curves on the Ability of Professionals to Identify Patient-ventilator Asynchronies N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Completed NCT05084976 - Parental Perception of COVID-19 Vaccine in Technology Dependent Patients
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Completed NCT04429399 - Lowering PEEP: Weaning From High PEEP Setting N/A
Completed NCT02249039 - Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study Phase 1
Recruiting NCT02071524 - Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics N/A
Completed NCT01114022 - Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane N/A
Completed NCT00893763 - Strategies To Prevent Pneumonia 2 (SToPP2) Phase 2
Terminated NCT05056103 - Automated Secretion Removal in ICU Patients N/A
Active, not recruiting NCT04558476 - Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation Phase 2
Recruiting NCT05295186 - PAV Trial During SBT Trial
Active, not recruiting NCT05370248 - The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Completed NCT04589910 - Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound. N/A
Completed NCT04193254 - LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU
Not yet recruiting NCT03245684 - Assisted or Controlled Ventilation in Ards (Ascovent) N/A
Not yet recruiting NCT03259854 - Non Invasive Mechanical Ventilation VERSUS Oxygen MASK N/A
Completed NCT06332768 - NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients N/A