Evaluating extubation criteria for older patients after surgery
A Prospective Evaluation of Extubation Criteria in Patients Greater Than 59 Years of Age Following Anesthesia and Non-cardiac Surgery
This study is testing if certain guidelines can help older patients who have just had surgery breathe on their own successfully without needing to be put back on a breathing machine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6700 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04596735 on ClinicalTrials.gov |
What this trial studies
This observational study aims to prospectively evaluate the effectiveness of specific clinical criteria used to determine extubation success in patients aged 60 and older following non-cardiac and non-thoracic surgeries. By analyzing these criteria, the study seeks to reduce the rates of reintubation and associated respiratory complications in this vulnerable population. The research will be conducted at Wake Forest University Health Sciences, focusing on patients who are expected to be extubated immediately after their procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 60 and older undergoing general endotracheal anesthesia for non-cardiac and non-thoracic surgical procedures.
Not a fit: Patients under 60 years of age or those undergoing cardiac or thoracic surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved extubation practices, reducing respiratory complications in elderly patients.
How similar studies have performed: While this approach is focused on a specific age group and type of surgery, similar studies have shown promise in improving extubation outcomes in older populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>= 60 years of age * Patients undergoing general endotracheal anesthesia for surgery or invasive diagnostic procedures that are anticipated to be extubated immediately following the procedure Exclusion Criteria: * Age\<60 years of age * Patients with a tracheostomy in - situ (pre-existing or placed as part of the index procedure) * Patients undergoing cardiac surgical procedures * Patients undergoing general endotracheal anesthesia who are not anticipated to be extubated immediately following the surgical procedure * Patients with delayed extubations in the post anesthesia care unit or intensive care unit) * Patients undergoing TIVA (Total Intravenous Anaesthesia) * Patient with an initial room air SpO2\<93% * Patients with VADS (ventricular assist device) undergoing non-cardiac surgery * Thoracic surgical procedures * Patients on home oxygen * Patients getting general anesthesia with supraglottic airway
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Thomas W Templeton, MD — Wake Forest Health Sciences
- Study coordinator: Lynnette C Harris
- Email: lcharris@wakehealth.edu
- Phone: 336-306-0778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.