Extubation Criteria in Patients Greater Than 59 Years of Age

Recruiting

• Conditions: Extubation; Respiratory Complications

• Registration Number: NCT04596735
• Lead Sponsor: Wake Forest University Health Sciences

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study Start: 2020-10-16
• Study First Posted: 2020-10-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6700

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extubation Success or Extubation requiring Intervention	Day 1	Quality of extubation will be assessed using a standard rubric for all extubation.
Presence or Absence of specific extubation criteria.	Day 1	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Preoperative Exposures (Regional Anesthesia other than local infiltration)	during procedure
Number of Participants with Preoperative Exposures (Type of inhalational agent used for maintenance)	during procedure	Qualitative measures will be used to analyze this Outcome Measure
Number of Participants with Preoperative Exposures (Use of train of 4 monitoring)	during procedure	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
Number of Participants with Preoperative Exposures (Use of Sugammadex for reversal)	during procedure
Number of Participants with Preoperative Exposures (Use of Neostigmine for reversal)	during procedure
Number of Participants with Preoperative Exposures (Difficult Airway)	during procedure	Difficult Airway or use of alternative airway technique other than DL because of suspected difficulty with the airway
Number of Participants with Preoperative Exposures (Intracranial Procedure)	during procedure
Number of Participants with Preoperative Exposures (positive end-expiratory pressure (PEEP)	during procedure	(PEEP) positive end-expiratory pressure \>7 cmH2O for \>10 minutes
Number of Participants with Preoperative Exposures (Surgical Procedure)	during procedure
Number of Participants with Preoperative Exposures (Open Abdominal)	during procedure
Number of Participants with Preoperative Exposures (Laparoscopic or Robotic Procedure)	during procedure
IV fluid volume	during procedure
volume of blood products	during procedure
types of blood products	during procedure
Number of Participants with Preoperative Exposures (use of colloid)	during procedure
volume of colloid	during procedure
Anesthesia Time during procedure	during procedure
Number of Participants with Preoperative Exposures (Use of (NMB) Neuromuscular Blocker	during procedure
Number of Participants with Preoperative Exposures (Use of Midazolam)	during procedure
Number of Participants with Preoperative Exposures (Use of opioid agonist during preoperative or intraoperative phase)	during procedure
Number of Participants with Preoperative Exposures (Use of blood or other blood products such as platelets, FFP(Fresh frozen plasma), or Cryo)	during procedure
Number of Participants with Preoperative Exposures (ASA) American Society of Anesthesiologists Emergency Status	Preoperative	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
Number of Participants with Preoperative Exposures (COPD) Chronic obstructive pulmonary disease	Preoperative	presence of COPD
Number of Participants with Preoperative Exposures (Dementia)	Preoperative	presence of dementia
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)	Preoperative	obstructive sleep apnea SCORE \>3
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)	Preoperative	STOP BANG SCORE \>3
Number of Participants with Preoperative Exposures (Neuro-degenerative disorders)	Preoperative	Neuro-degenerative disorders such as: amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis, Alzheimer's, Huntington's
Number of Participants with Preoperative Exposures (Heart failure)	Preoperative	by history or documented echo
Number of Participants with Preoperative Exposures (Opioid naïve)	Preoperative	by history or from electronic health record
Number of Participants with Preoperative Exposures (Diabetes)	Preoperative	presence of diabetes mellitus
Number of Participants with Preoperative Exposures (ESRD) End-Stage Renal Disease	Preoperative	presence of end-stage renal disease
Number of Participants with Preoperative Exposures (CVA) cerebrovascular accident - medical term for a stroke	Preoperative
Number of Participants with Preoperative Exposures (Chronic Restrictive Lung disease)	Preoperative
Number of Participants with Preoperative Exposures (Current Smoker)	Preoperative	current smoker or \>=20 year pack history
Number of Participants with Preoperative Exposures (Inhalational agent used for maintenance)	Preoperative	Anesthetic maintenance agent used at time of extubation

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States