Perioperative Vaping Complications

NCT ID: NCT05912023

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-28

Study Completion Date

2025-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Vaping Complication of Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaping patients

Includes patients that actively vape that are undergoing general anesthesia

No interventions assigned to this group

Non-vaping patients

Includes patients that do not actively vape that are undergoing general anesthesia

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navy Medical Center San Diego

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Naval Medical Center San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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NMRTCSD.2023.0006

Identifier Type: -

Identifier Source: org_study_id

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