Perioperative Vaping Complications

Active, not recruiting

• Conditions: Complication of Anesthesia; Vaping

• Registration Number: NCT05912023
• Lead Sponsor: Navy Medical Center San Diego

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 Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Study Start: 2023-07-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-01-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative pulmonary complications	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 Outcome Measures

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

Trial Locations

Locations (1)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States