Clinical trial NCT04596735: Extubation Criteria in Patients Greater Than 59 Years of Age
Official title: A Prospective Evaluation of Extubation Criteria in Patients Greater Than 59 Years of Age Following Anesthesia and Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extubation
Respiratory Complications
Keywords: non-cardiac surgery
non-thoracic surgery
reintubation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 6700
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 60 years of age and older undergoing general anesthesia and non-cardiac surgery will be observed by a member of the research team independent from the team caring for the patient at the time of emergence and extubation

Brief summary: Prospectively evaluate the predictive value of individual pre-specified clinical extubation criteria for extubation success

Detailed description: Perform a prospective observational study to evaluate routine criteria commonly used to extubate elderly patients in the operating room after non-cardiac and non-thoracic surgery to ultimately reduce the incidence of near-term reintubation and by extension other respiratory complications

Eligibility 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

Primary outcomes:
measure: Extubation Success or Extubation requiring Intervention
timeFrame: Day 1
measure: Presence or Absence of specific extubation criteria.
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants with Preoperative Exposures (ASA) American Society of Anesthesiologists Emergency Status
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (COPD) Chronic obstructive pulmonary disease
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Dementia)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (obstructive sleep apnea by history or STOP BANG) (snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference and gender)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Sleep Disordered breathing by history or STOP BANG) (snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference and gender)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Neuro-degenerative disorders)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Heart failure)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Opioid naïve)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Diabetes)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (ESRD) End-Stage Renal Disease
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (CVA) cerebrovascular accident - medical term for a stroke
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Chronic Restrictive Lung disease)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Current Smoker)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Inhalational agent used for maintenance)
timeFrame: Preoperative
measure: Number of Participants with Preoperative Exposures (Use of (NMB) Neuromuscular Blocker
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Use of Midazolam)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Use of opioid agonist during preoperative or intraoperative phase)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Use of blood or other blood products such as platelets, FFP(Fresh frozen plasma), or Cryo)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Regional Anesthesia other than local infiltration)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Type of inhalational agent used for maintenance)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Use of train of 4 monitoring)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Use of Sugammadex for reversal)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Use of Neostigmine for reversal)
timeFrame: during procedure
measure: Anesthesia Time during procedure
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Difficult Airway)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Intracranial Procedure)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (positive end-expiratory pressure (PEEP)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Surgical Procedure)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Open Abdominal)
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (Laparoscopic or Robotic Procedure)
timeFrame: during procedure
measure: IV fluid volume
timeFrame: during procedure
measure: volume of blood products
timeFrame: during procedure
measure: types of blood products
timeFrame: during procedure
measure: Number of Participants with Preoperative Exposures (use of colloid)
timeFrame: during procedure
measure: volume of colloid
timeFrame: during procedure
Other outcomes:
measure: Hospital stay
timeFrame: day 60
measure: 30 day Mortality Rate
timeFrame: day 30
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Thomas W Templeton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behrendt CE. Acute respiratory failure in the United States: incidence and 31-day survival. Chest. 2000 Oct;118(4):1100-5. doi: 10.1378/chest.118.4.1100.
citation: Alvarez MP, Samayoa-Mendez AX, Naglak MC, Yuschak JV, Murayama KM. Risk Factors for Postoperative Unplanned Intubation: Analysis of a National Database. Am Surg. 2015 Aug;81(8):820-5.
citation: Tillquist MN, Gabriel RA, Dutton RP, Urman RD. Incidence and risk factors for early postoperative reintubations. J Clin Anesth. 2016 Jun;31:80-9. doi: 10.1016/j.jclinane.2015.12.038. Epub 2016 Apr 12.