Perioperative Vaping Complications

Sponsor

Navy Medical Center San Diego (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05912023

Collaborator

(none)

300

Enrollment

Location

7.1

Anticipated Duration (Months)

42.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vaping Associated Perioperative Pulmonary Complications - Anesthetic Implications

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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 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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center San Diego	San Diego	California	United States	92134

Sponsors and Collaborators

Navy Medical Center San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Navy Medical Center San Diego

ClinicalTrials.gov Identifier:

NCT05912023

Other Study ID Numbers:

NMRTCSD.2023.0006

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Navy Medical Center San Diego

Study Results

No Results Posted as of Jun 22, 2023