Perioperative Vaping Complications

Vaping Associated Perioperative Pulmonary Complications - Anesthetic Implications

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

Study Overview

• Status: Active, not recruiting
• Conditions: Vaping; Complication of Anesthesia

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Jeffrey M Carness, MD; Phone Number: 360-908-3804; Email: jeffcarness@gmail.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego
      • Contact: Jose-Ramon R Troche, MPH, PhD; Phone Number: 619-532-5524; Email: joseramon.r.troche.civ@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients, both those that vape and those that do not, who meet the inclusion criteria and receive general anesthesia to facilitate surgical intervention at Naval Medical Center San Diego.

Description

Inclusion Criteria:

• Surgical Patient
• General Anesthesia
• Hx of vaping
• Age ≥12

Exclusion Criteria:

• Age <12
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Vaping patients; Includes patients that actively vape that are undergoing general anesthesia
Non-vaping patients; Includes patients that do not actively vape that are undergoing general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative pulmonary complications	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.	From the initiation of general anesthesia through postoperative day seven.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaping cessation timeline	Includes the relationship between vaping cessation timeline in the preoperative period and the occurrence of postoperative pulmonary complications	From the initiation of general anesthesia through postoperative day seven.

Collaborators and Investigators

• Sponsor: Navy Medical Center San Diego

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Perioperative; Vaping; Bronchospasm; Hypoxemia; Pneumonitis
• Other Study ID Numbers: NMRTCSD.2023.0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No