VapingNCT05912023
Perioperative Vaping Complications
An observational study of Vaping and Complication of Anesthesia, run by Navy Medical Center San Diego at 1 site in United States.
Trial summary
Prospective observational study evaluating the incidence, and qualifying the types, of perioperative pulmonary complications in patients that vape. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Vaping, Complication of Anesthesia
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 1 Jul 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Surgical Patient
- General Anesthesia
- Hx of vaping
- Age ≥12
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Vaping Associated Perioperative Pulmonary Complications - Anesthetic Implications
Prospective observational study evaluating the incidence, and qualifying the types, of perioperative pulmonary complications in patients that vape.
Read the 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.
- Conditions
- Vaping, Complication of Anesthesia
- Keywords
- Vaping, Hypoxemia, Bronchospasm, Perioperative, Pneumonitis
- Medical subject headings
- Vaping, Hypoxia, Bronchial Spasm, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the initiation of general anesthesia through postoperative day seven.
Secondary outcomes (1)
Vaping cessation timeline
Includes the relationship between vaping cessation timeline in the preoperative period and the occurrence of postoperative pulmonary complications
Measured: From the initiation of general anesthesia through postoperative day seven.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start28 Jul 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Navy Medical Center San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912023
- Sponsor's protocol ID
- NMRTCSD.2023.0006
- Status last verified
- May 2024
- First submitted
- 12 Jun 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaping Associated Perioperative Pulmonary Complications - Anesthetic Implications
- ClinicalTrials.gov ID
- NCT05912023
- Acronym / sponsor ID
- NMRTCSD.2023.0006
- Conditions
- Vaping, Complication of Anesthesia
- Keywords
- Vaping, Hypoxemia, Bronchospasm, Perioperative, Pneumonitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Navy Medical Center San DiegoUS federal agency
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Surgical Patient
- General Anesthesia
- Hx of vaping
- Age ≥12
Key exclusion criteria (7 listed)
- Age <12
- Pregnancy
- Active preoperative pulmonary infection
- Recent pulmonary infection (within 8 weeks)
- Active tobacco smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative pulmonary complications
Time frame: 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.
1 secondary outcome
Vaping cessation timeline
Time frame: From the initiation of general anesthesia through postoperative day seven.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
Related trials for Vaping
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Recruiting
Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
Tobacco Products, Cigarettes
Recruiting
Circuit Breathing Exercise on Smoking Cessation Among Youth E-Cigarette Users
E Cigarette Use
Recruiting
A Behavioral Circuit Breathing Training Intervention on Smoking Cessation and Respiratory Function Among Youth Who Use E-cigarettes
E Cigarette Use
Not yet recruiting
Cardiovascular Impacts of E-cigarettes Among Older Adults
Hypertension, Tobacco Cigarette Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaping and Complication of Anesthesia, run by Navy Medical Center San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative pulmonary complications (time frame: From the initiation of general anesthesia through postoperative day seven.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.