Extubation Clinical Trial
Official title:
A Prospective Evaluation of Extubation Criteria in Patients Greater Than 59 Years of Age Following Anesthesia and Non-cardiac Surgery
| NCT number | NCT04596735 |
| Other study ID # | IRB00063713 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 16, 2020 |
| Est. completion date | July 2024 |
Prospectively evaluate the predictive value of individual pre-specified clinical extubation criteria for extubation success
| Status | Recruiting |
| Enrollment | 6700 |
| Est. completion date | July 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Wake Forest Health Sciences | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Wake Forest University Health Sciences |
United States,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Hospital stay | length of stay | day 60 | |
| Other | 30 day Mortality Rate | 30 Day mortality obtained from the chart in order to determine association with intervention required at extubation | day 30 | |
| Primary | Extubation Success or Extubation requiring Intervention | Quality of extubation will be assessed using a standard rubric for all extubation. | Day 1 | |
| Primary | 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 | Day 1 | |
| Secondary | 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 | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (COPD) Chronic obstructive pulmonary disease | presence of COPD | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (Dementia) | presence of dementia | Preoperative | |
| Secondary | 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 | Preoperative | |
| Secondary | 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 | Preoperative | |
| Secondary | 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 | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (Heart failure) | by history or documented echo | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (Opioid naïve) | by history or from electronic health record | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (Diabetes) | presence of diabetes mellitus | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (ESRD) End-Stage Renal Disease | presence of end-stage renal disease | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (CVA) cerebrovascular accident - medical term for a stroke | Preoperative | ||
| Secondary | Number of Participants with Preoperative Exposures (Chronic Restrictive Lung disease) | Preoperative | ||
| Secondary | Number of Participants with Preoperative Exposures (Current Smoker) | current smoker or >=20 year pack history | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (Inhalational agent used for maintenance) | Anesthetic maintenance agent used at time of extubation | Preoperative | |
| Secondary | Number of Participants with Preoperative Exposures (Use of (NMB) Neuromuscular Blocker | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (Use of Midazolam) | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (Use of opioid agonist during preoperative or intraoperative phase) | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (Use of blood or other blood products such as platelets, FFP(Fresh frozen plasma), or Cryo) | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (Regional Anesthesia other than local infiltration) | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (Type of inhalational agent used for maintenance) | Qualitative measures will be used to analyze this Outcome Measure | during procedure | |
| Secondary | 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 | during procedure | |
| Secondary | Number of Participants with Preoperative Exposures (Use of Sugammadex for reversal) | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (Use of Neostigmine for reversal) | during procedure | ||
| Secondary | Anesthesia Time during procedure | during procedure | ||
| Secondary | 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 | during procedure | |
| Secondary | Number of Participants with Preoperative Exposures (Intracranial Procedure) | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (positive end-expiratory pressure (PEEP) | (PEEP) positive end-expiratory pressure >7 cmH2O for >10 minutes | during procedure | |
| Secondary | Number of Participants with Preoperative Exposures (Surgical Procedure) | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (Open Abdominal) | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (Laparoscopic or Robotic Procedure) | during procedure | ||
| Secondary | IV fluid volume | during procedure | ||
| Secondary | volume of blood products | during procedure | ||
| Secondary | types of blood products | during procedure | ||
| Secondary | Number of Participants with Preoperative Exposures (use of colloid) | during procedure | ||
| Secondary | volume of colloid | during procedure |
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