Perioperative Vaping Complications

Vaping Clinical Trial

Official title:

Vaping Associated Perioperative Pulmonary Complications - Anesthetic Implications

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05912023
• Other study ID #: NMRTCSD.2023.0006
• Status: Active, not recruiting
• Start date: July 28, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: Navy Medical Center San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Anesthesia
• Vaping

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Navy Medical Center San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.