Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05904652
Other study ID # GN23CC122
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 7, 2023
Est. completion date September 7, 2024

Study information

Verified date November 2023
Source NHS Greater Glasgow and Clyde
Contact Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM
Phone +44(0)1412014500
Email malcolm.sim@ggc.scot.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this feasibility study is to learn whether a new approach to breathing tube removal within the Intensive Care Unit is safe and acceptable to participants who require a breathing tube for the management of severe breathing difficulties. The main questions it aims to answer are: - What is the recruitment rate to the study over 12 months? - Is the study design acceptable and safe to participants? Participants will receive high flow nasal oxygen before their breathing tube is removed. The investigators will compare this with standard practice of applying conventional, low-flow oxygen after the breathing tube removed to see if this effects the rate of repeat breathing tube insertion. The investigators hypothesise that they will recruit 30 participants to the study protocol (15 participants in each group) over 12 months and that our study protocol will be tolerable and acceptable to participants.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fisher and Paykel "HealthCare Airvo™ 3" high flow system
High Flow Nasal Oxygen Delivery Device
Conventional Oxygen Therapy
Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute)

Locations

Country Name City State
United Kingdom Department of Critical Care Medicine, Queen Elizabeth University Hospital Glasgow Scotland

Sponsors (3)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde Fisher and Paykel Healthcare, LINET

Country where clinical trial is conducted

United Kingdom, 

References & Publications (15)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care. The associated end point will be the average rate of recruitment per month over 12 months of participants who complete the full study protocol (with a set upper limit of 30 participants recruited to the protocol over 12 months corresponding to a recruitment rate of 2.5 participants per month). 12 months
Secondary The incidence of Adverse Events and Serious Adverse Events associated with trial procedures. This will focus primarily on aspects of SAFEx and Electrical Impedance Tomography Measurement. 72 hours
Secondary Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care. Questions will ask participants to rate their experience on a 1 to 10 scale for:
Overall comfort
Perceived dyspnoea
Ability to speak
Ability to hear
Ability to clear secretions
Sensation of bloating
Sensation of dry mouth
Sensation of nasal dryness
Fear
72 hours
Secondary Withdrawal rate from the study. The number of participants requesting to withdraw from the study due to inability to tolerate the trial procedures. 72 hours
Secondary The rate of completion of the SAFEx weaning protocol. The percentage of participants who completed the weaning protocol without breaching any of the physiological participant safety criteria. 2 hours 50 minutes
Secondary The duration of weaning tolerated before desaturation occurred. The average fraction of inspired oxygen and oxygen flow rate administered in each group before desaturation occurred. 2 hours 50 minutes
Secondary The failure rate of Electrical Impedance Tomography measurement. Defined as the proportion of participants in whom impedance data cannot be computed. 2 hours 50 minutes
Secondary The participant self-rated Visual Analogue Scale score for questions exploring the tolerability of Electrical Impedance Tomography Measurement. Questions will ask participants to rate their experience on a 1 to 10 scale for:
Overall comfort whilst wearing EIT
Overall comfort on removal of EIT
Overall ease of breathing with EIT
72 hours
Secondary The change in global electrical impedance between each group. The change in end expiratory lung impedance and delta impedance between each group. 2 hours 50 minutes
Secondary The reintubation rate in each group. The rate of repeat intubation will be measured in each group at 24, 48 and 72 hours post-extubation. 72 hours
See also
  Status Clinical Trial Phase
Completed NCT04030208 - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT02930525 - Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation N/A
Recruiting NCT02539732 - Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Completed NCT02056119 - RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit N/A
Terminated NCT01583088 - Early Stage Amyotrophic Lateral Sclerosis Phrenic Stimulation Phase 3
Withdrawn NCT00990119 - High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT00741949 - Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF Phase 3
Completed NCT01411722 - Electrical Activity of the Diaphragm During the Weaning Period Phase 2
Recruiting NCT00339053 - Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair Phase 4
Recruiting NCT00187434 - Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP) N/A
Completed NCT02687802 - Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Not yet recruiting NCT05906030 - Diaphragm Dysfunction and Ultrasound Perioperatively
Completed NCT03850977 - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Completed NCT02845375 - Effect of Neuromuscular Blockade and Reversal on Breathing Phase 4
Recruiting NCT03309423 - Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU? N/A
Completed NCT04115969 - Outcome After Non-invasive Ventilation.
Not yet recruiting NCT03687385 - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients N/A