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Clinical Trials/NCT05912023
NCT05912023Active, not recruitingNot Applicable

Vaping Associated Perioperative Pulmonary Complications - Anesthetic Implications

Navy Medical Center San Diego1 site in 1 country300 target enrollmentStarted: July 28, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
300
Locations
1
Primary Endpoint
Perioperative pulmonary complications

Study Overview

Brief Summary

Prospective observational study evaluating the incidence, and qualifying the types, of perioperative pulmonary complications in patients that vape.

Detailed Description

The primary objective of our study is to determine the rate at which patients that vape or use e-cigarettes experience perioperative pulmonary complications during and following general anesthesia. Complications of interest will include postoperative atelectasis with hypoxemia necessitating oxygen therapy, pneumothorax, pneumonia, bronchospasm, bronchospasm requiring bronchodilator therapy, exacerbation of underlying pulmonary disease, pneumonia, ARDS, and acute respiratory failure. Hospital course, including prolonged PACU stay, prolonged hospital admission for inpatients, and rate of ICU admissions, will also be investigated.

A secondary objective will be to further investigate and include the relationship between vaping cessation timeline in the preoperative period and the occurrence of PPCs, which is similarly underreported in the literature. Furthermore, the study will assess how effectively anesthesia providers are screening for vaping or e-cigarette use as part of the preoperative evaluation, given that "it is unclear whether anesthesiologists and surgeons routinely ask patients explicitly about vaping" in the pre-operative setting. This lack of representative screening for vaping further obscures an understanding of the relationship between vaping, vaping cessation, and PPCs.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Surgical Patient
  • General Anesthesia
  • Hx of vaping

Exclusion Criteria

  • Pregnancy
  • Active preoperative pulmonary infection
  • Recent pulmonary infection (within 8 weeks)
  • Active tobacco smoker
  • Poorly controlled reactive airway disease (requires more than PRN albuterol)
  • Non-Lung Protective Ventilation

Outcomes

Primary Outcomes

Perioperative pulmonary complications

Time Frame: From the initiation of general anesthesia through postoperative day seven.

Complications of interest will include postoperative atelectasis with hypoxemia necessitating oxygen therapy, pneumothorax, pneumonia, bronchospasm, bronchospasm requiring bronchodilator therapy, exacerbation of underlying pulmonary disease, pneumonia, ARDS, and acute respiratory failure. Hospital course, including prolonged PACU stay, prolonged hospital admission for inpatients, and rate of ICU admissions, will also be investigated.

Secondary Outcomes

  • Vaping cessation timeline(From the initiation of general anesthesia through postoperative day seven.)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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