Perioperative Vaping Complications

NCT05912023 | Active Not Recruiting

• 1 other identifier: NMRTCSD.2023.0006
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaping; Complication of Anesthesia

Keywords

Vaping; Hypoxemia; Bronchospasm; Perioperative; Pneumonitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vaping cessation timeline

  From the initiation of general anesthesia through postoperative day seven.

Study Arms (2)

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

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Navy Medical Center San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Vaping; Hypoxia; Bronchial Spasm; Pneumonia

Condition Hierarchy (Ancestors)

Smoking; Behavior; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: July 28, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)