Extubation Criteria in Patients Greater Than 59 Years of Age

Wake Forest University Health Sciences4,000 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

4,000

Conditions

Extubation Respiratory Complications

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Extubation Success or Extubation requiring Intervention

Quality of extubation will be assessed using a standard rubric for all extubation.

Time frame: Day 1

Presence or Absence of specific extubation criteria.

Assess the presence of specific extubation criteria met during extubation from the following list: Following Commands, Tidal volume\>4 cc/kg, Conjugate gaze, End-tidal CO2 (ETCO2) \<55 mmHg, ET agent concentration \< (Des 1%, Iso \<=0.2%, Sevo \<0.3%, oxygen saturation (SpO2) \> 94%,Qualitative or quantitative Tetralogy of Fallot (TOF), Purposeful Movement, 5 second head lift, Spontaneous Respiratory Rate \>=8 bpm at extubation, eye opening

Time frame: Day 1

Secondary Outcomes

Number of Participants with Preoperative Exposures (ASA) American Society of Anesthesiologists Emergency Status

The classification system alone does not predict the perioperative risks, but used with other factors (eg, type of surgery, frailty, level of deconditioning), it can be helpful in predicting perioperative risks

Time frame: Preoperative

Number of Participants with Preoperative Exposures (COPD) Chronic obstructive pulmonary disease

presence of COPD

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Dementia)

presence of dementia

Time frame: Preoperative

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)

obstructive sleep apnea SCORE \>3

Time frame: Preoperative

Data from ClinicalTrials.gov

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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)

STOP BANG SCORE \>3

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Neuro-degenerative disorders)

Neuro-degenerative disorders such as: amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis, Alzheimer's, Huntington's

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Heart failure)

by history or documented echo

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Opioid naïve)

by history or from electronic health record

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Diabetes)

presence of diabetes mellitus

Time frame: Preoperative

Number of Participants with Preoperative Exposures (ESRD) End-Stage Renal Disease

presence of end-stage renal disease

Time frame: Preoperative

Number of Participants with Preoperative Exposures (CVA) cerebrovascular accident - medical term for a stroke

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Chronic Restrictive Lung disease)

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Current Smoker)

current smoker or \>=20 year pack history

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Inhalational agent used for maintenance)

Anesthetic maintenance agent used at time of extubation

Time frame: Preoperative

Number of Participants with Preoperative Exposures (Use of (NMB) Neuromuscular Blocker

Time frame: during procedure

Number of Participants with Preoperative Exposures (Use of Midazolam)

Time frame: during procedure

Number of Participants with Preoperative Exposures (Use of opioid agonist during preoperative or intraoperative phase)

Time frame: during procedure

Number of Participants with Preoperative Exposures (Use of blood or other blood products such as platelets, FFP(Fresh frozen plasma), or Cryo)

Time frame: during procedure

Number of Participants with Preoperative Exposures (Regional Anesthesia other than local infiltration)

Time frame: during procedure

Number of Participants with Preoperative Exposures (Type of inhalational agent used for maintenance)

Qualitative measures will be used to analyze this Outcome Measure

Time frame: during procedure

Number of Participants with Preoperative Exposures (Use of train of 4 monitoring)

A peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity

Time frame: during procedure

Number of Participants with Preoperative Exposures (Use of Sugammadex for reversal)

Time frame: during procedure

Number of Participants with Preoperative Exposures (Use of Neostigmine for reversal)

Time frame: during procedure

Anesthesia Time during procedure

Time frame: during procedure

Number of Participants with Preoperative Exposures (Difficult Airway)

Difficult Airway or use of alternative airway technique other than DL because of suspected difficulty with the airway

Time frame: during procedure

Number of Participants with Preoperative Exposures (Intracranial Procedure)

Time frame: during procedure

Number of Participants with Preoperative Exposures (positive end-expiratory pressure (PEEP)

(PEEP) positive end-expiratory pressure \>7 cmH2O for \>10 minutes

Time frame: during procedure

Number of Participants with Preoperative Exposures (Surgical Procedure)

Time frame: during procedure

Number of Participants with Preoperative Exposures (Open Abdominal)

Time frame: during procedure

Number of Participants with Preoperative Exposures (Laparoscopic or Robotic Procedure)

Time frame: during procedure

IV fluid volume

Time frame: during procedure

volume of blood products

Time frame: during procedure

types of blood products

Time frame: during procedure

Number of Participants with Preoperative Exposures (use of colloid)

Time frame: during procedure

volume of colloid

Time frame: during procedure