Clinical Trials Logo
  1. Home
  2. Respiratory Failure
  3. NCT03944967
  4. Details
NCT03944967 Clinical Trial

Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

Respiratory Failure Clinical Trial

— AGEAWARE  

Official title:
Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03944967
Other study ID # NL68944.100.19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 5, 2020
Est. completion date December 19, 2021

Study information
Verified date November 2023
Source St. Antonius Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients. - Single center pilot study. - 100 older patients undergoing cardiac surgery. - Continuous remote monitoring of vital signs after ICU discharge - Main study endpoint is vital sign deterioration.

Description:

Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery. To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients.. - Single center pilot study. - 100 older patients undergoing cardiac surgery. - Continuous remote monitoring of vital signs starts after ICU discharge - PR, RR and SpO2 will be continuously monitored in all patients. - Patients and healthcare personnel are blinded for monitoring results. - Main study endpoint is vital sign deterioration. The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date December 19, 2021
Est. primary completion date December 19, 2021
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - =70 years undergoing elective cardiac surgery. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands St Antonius hospital Nieuwegein Utrecht

Sponsors (1)
Lead Sponsor Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypoxemia Duration of sPO2 <80%, <85%, <90% and <95% in minutes per hour Three consecutive days after ICU discharge
Primary Respiratory deterioration Duration of respiratory rate <10 min-1, >20 min-1, >25 min-1, >30 min-1 in minutes per hour Three consecutive days after ICU discharge
Primary Arrythmia Duration of pulse rate <50 min-1, >100 min-1, >110 min-1, >120 min-1 in minutes per hour Three consecutive days after ICU discharge
See also
  Status Clinical Trial Phase
Completed NCT03909854 - Pragmatic Investigation of Volume Targeted Ventilation-1 N/A
Recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT05535543 - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed NCT04030208 - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation N/A
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT04668313 - COVID-19 Advanced Respiratory Physiology (CARP) Study
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04505592 - Tenecteplase in Patients With COVID-19 Phase 2
Completed NCT03943914 - Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients. N/A
Active, not recruiting NCT03472768 - The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Completed NCT02265198 - Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome N/A
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01659268 - Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins N/A
Completed NCT02814994 - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients N/A
Completed NCT01249794 - Non Invasive Ventilation After Cardiac Surgery N/A
Terminated NCT01333059 - Cycling of Sedative Infusions in Critically Ill Pediatric Patients N/A