Exposure to Environmental PollutionNCT02725164
Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes
A study testing oxygen concentration, nitrous oxide concentration and carbon dioxide concentration in people with Exposure to Environmental Pollution and Adverse Effect of Unspecified General Anesthetic, run by State University of New York at Buffalo.
Trial summary
Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx during airway surgery. Investigators sought to measure the concentrations of anesthetic gases that leak into the mouth of children undergoing adenotonsillectomy using cuffed and uncuffed tracheal tubes during spontaneous and… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Exposure to Environmental Pollution, Adverse Effect of Unspecified General Anesthetic
- What is being tested?
- oxygen concentration, nitrous oxide concentration and carbon dioxide concentration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2016to 1 Jun 2016
- Phase
- Interventional
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of anesthesiologists physical status 1 and 2;
- fasted
- scheduled for elective adenotonsillectomy
Who cannot join
- refusal of consent by parents
- difficult tracheal intubation
- craniofacial anomalies
- gastroesophageal reflux
- malignant hyperthermia
- randomization to a tracheal tube is unacceptable.
About this study
Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx during airway surgery. Investigators sought to measure the concentrations of anesthetic gases that leak into the mouth of children undergoing adenotonsillectomy using cuffed and uncuffed tracheal tubes during spontaneous and controlled ventilation.
Read the detailed description
For the past 6 decades, uncuffed tubes have been used for the children less than 8 years of age out of a fear that cuffed tubes would cause damage to the subglottic region. The correct size uncuffed tube creates a seal in the subglottis that has minimal pressure on the mucosa. However, cuffed tubes have become more widely used in children recently without causing damage to the mucosa. There is very little literature comparing the magnitude of the gas leaks with cuffed and uncuffed tracheal tubes particularly in children. Several authors suggest that the leak of nitrous oxide and sevoflurane with uncuffed tubes was much greater than with cuffed tubes. One important but poorly studied issue is the risk of an airway fire when cautery is used for tonsillectomy because a large leak of oxygen in the mouth could ignite a fire. It also remains unclear whether the mode of ventilation, spontaneous or controlled, affects the leak of gases into the mouth. One might expect that the gas leak with spontaneous ventilation is less than with controlled ventilation, but it may not matter in the context of the small concentrations of oxygen and sevoflurane that investigators use. To address all of these concerns, investigators designed this study to compare the concentrations of gases (oxygen, carbon dioxide, nitrous oxide and sevoflurane) in the oral cavity of children undergoing T\&A with either cuffed or uncuffed tubes, during spontaneous and controlled ventilation.
- Being tested
- oxygen concentration, nitrous oxide concentration, carbon dioxide concentration, sevoflurane concentration
- Keywords
- oxygen, nitrous oxide, sevoflurane, carbon dioxide, endotracheal tube, respiration
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen concentrationDrug
Also called difference in the oxygen concentration
oxygen concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
nitrous oxide concentrationDrug
Also called difference in the nitrous oxide concentration
nitrous oxide concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
carbon dioxide concentrationDrug
Also called difference in the carbon dioxide concentration
carbon dioxide concentration will be measured from the tracheal tube and in the oropharynx during spontaneous or controlled ventilation
sevoflurane concentrationDrug
Also called difference in the sevoflurane concentration
sevoflurane concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
| Study group | Role | What they receive |
|---|---|---|
| Uncuffed tracheal tubes | Placebo comparator | After tracheal intubation with an uncuffed tube, the interventions will be the oxygen concentration, nitrous oxide concentration, carbon dioxide concentration and sevoflurane concentration measured in the tracheal tube compared with those in the oropharynx during spontaneous and controlled ventilation. Receives: Drug: oxygen concentration; Drug: nitrous oxide concentration; Drug: carbon dioxide concentration; Drug: sevoflurane concentration |
| Cuffed tracheal tubes | Active comparator | After tracheal intubation with a cuffed tube, the interventions will be the oxygen concentration, nitrous oxide concentration, carbon dioxide concentration and sevoflurane concentration measured in the tracheal tube compared with those in the oropharynx during spontaneous and controlled ventilation. Receives: Drug: oxygen concentration; Drug: nitrous oxide concentration; Drug: carbon dioxide concentration; Drug: sevoflurane concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the oxygen concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
The differences in the oxygen concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Measured: 8 months
Secondary outcomes (3)
Difference in the nitrous oxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
The differences in the nitrous oxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Measured: 8 months
Difference in the carbon dioxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
The differences in the carbon dioxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Measured: 8 months
Difference in the sevoflurane concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
The differences in the sevoflurane concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start12 Apr 2016
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exposure to Environmental PollutionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrold Lerman, State University of New York at Buffalo
- Investigators
- Jerrold Lerman, MD, FRCPC, Principal investigator, Women & Children's Hospital of Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725164
- Sponsor's protocol ID
- Gas leak during tonsillectomy
- Status last verified
- Feb 2017
- First submitted
- 25 Mar 2016
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiss M, Dullenkopf A, Gysin C, Dillier CM, Gerber AC. Shortcomings of cuffed paediatric tracheal tubes. Br J Anaesth. 2004 Jan;92(1):78-88. doi: 10.1093/bja/aeh023.
PubMed 14665558Khine HH, Corddry DH, Kettrick RG, Martin TM, McCloskey JJ, Rose JB, Theroux MC, Zagnoev M. Comparison of cuffed and uncuffed endotracheal tubes in young children during general anesthesia. Anesthesiology. 1997 Mar;86(3):627-31; discussion 27A. doi: 10.1097/00000542-199703000-00015.
PubMed 9066329Eschertzhuber S, Salgo B, Schmitz A, Roth W, Frotzler A, Keller CH, Gerber AC, Weiss M. Cuffed endotracheal tubes in children reduce sevoflurane and medical gas consumption and related costs. Acta Anaesthesiol Scand. 2010 Aug;54(7):855-8. doi: 10.1111/j.1399-6576.2010.02261.x. Epub 2010 Jun 15.
PubMed 20560884Mehta SP, Bhananker SM, Posner KL, Domino KB. Operating room fires: a closed claims analysis. Anesthesiology. 2013 May;118(5):1133-9. doi: 10.1097/ALN.0b013e31828afa7b.
PubMed 23422795Raman V, Tobias JD, Bryant J, Rice J, Jatana K, Merz M, Elmaraghy C, Kang DR. Effect of cuffed and uncuffed endotracheal tubes on the oropharyngeal oxygen and volatile anesthetic agent concentration in children. Int J Pediatr Otorhinolaryngol. 2012 Jun;76(6):842-4. doi: 10.1016/j.ijporl.2012.02.055. Epub 2012 Mar 23.
PubMed 22444738
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes
- ClinicalTrials.gov ID
- NCT02725164
- Acronym / sponsor ID
- Gas leak during tonsillectomy
- Keywords
- oxygen, nitrous oxide, sevoflurane, carbon dioxide, endotracheal tube, respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx during airway surgery. Investigators sought to measure the concentrations of anesthetic gases that leak into the mouth of children undergoing adenotonsillectomy using cuffed and uncuffed tracheal tubes during spontaneous and controlled ventilation.
Detailed description
For the past 6 decades, uncuffed tubes have been used for the children less than 8 years of age out of a fear that cuffed tubes would cause damage to the subglottic region. The correct size uncuffed tube creates a seal in the subglottis that has minimal pressure on the mucosa. However, cuffed tubes have become more widely used in children recently without causing damage to the mucosa. There is very little literature comparing the magnitude of the gas leaks with cuffed and uncuffed tracheal tubes particularly in children. Several authors suggest that the leak of nitrous oxide and sevoflurane with uncuffed tubes was much greater than with cuffed tubes. One important but poorly studied issue is the risk of an airway fire when cautery is used for tonsillectomy because a large leak of oxygen in the mouth could ignite a fire. It also remains unclear whether the mode of ventilation, spontaneous or controlled, affects the leak of gases into the mouth. One might expect that the gas leak with spontaneous ventilation is less than with controlled ventilation, but it may not matter in the context of the small concentrations of oxygen and sevoflurane that investigators use. To address all of these concerns, investigators designed this study to compare the concentrations of gases (oxygen, carbon dioxide, nitrous oxide and sevoflurane) in the oral cavity of children undergoing T\&A with either cuffed or uncuffed tubes, during spontaneous and controlled ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncuffed tracheal tubes | Placebo comparator | Drug: oxygen concentration, Drug: nitrous oxide concentration, Drug: carbon dioxide concentration, Drug: sevoflurane concentrationAfter tracheal intubation with an uncuffed tube, the interventions will be the oxygen concentration, nitrous oxide concentration, carbon dioxide concentration and sevoflurane concentration measured in the tracheal tube compared with those in the oropharynx during spontaneous and controlled ventilation. |
| Cuffed tracheal tubes | Active comparator | Drug: oxygen concentration, Drug: nitrous oxide concentration, Drug: carbon dioxide concentration, Drug: sevoflurane concentrationAfter tracheal intubation with a cuffed tube, the interventions will be the oxygen concentration, nitrous oxide concentration, carbon dioxide concentration and sevoflurane concentration measured in the tracheal tube compared with those in the oropharynx during spontaneous and controlled ventilation. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American society of anesthesiologists physical status 1 and 2;
- fasted
- scheduled for elective adenotonsillectomy
Key exclusion criteria (6 listed)
- refusal of consent by parents
- difficult tracheal intubation
- craniofacial anomalies
- gastroesophageal reflux
- malignant hyperthermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen concentrationAlso: difference in the oxygen concentrationoxygen concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation | Drug | Cuffed tracheal tubes, Uncuffed tracheal tubes |
| nitrous oxide concentrationAlso: difference in the nitrous oxide concentrationnitrous oxide concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation | Drug | Cuffed tracheal tubes, Uncuffed tracheal tubes |
| carbon dioxide concentrationAlso: difference in the carbon dioxide concentrationcarbon dioxide concentration will be measured from the tracheal tube and in the oropharynx during spontaneous or controlled ventilation | Drug | Cuffed tracheal tubes, Uncuffed tracheal tubes |
| sevoflurane concentrationAlso: difference in the sevoflurane concentrationsevoflurane concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation | Drug | Cuffed tracheal tubes, Uncuffed tracheal tubes |
Primary outcome
Difference in the oxygen concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Time frame: 8 months
The differences in the oxygen concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
3 secondary outcomes
Difference in the nitrous oxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Time frame: 8 months
Difference in the carbon dioxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Time frame: 8 months
Difference in the sevoflurane concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Background: PubMed 14665558Weiss M, Dullenkopf A, Gysin C, Dillier CM, Gerber AC. Shortcomings of cuffed paediatric tracheal tubes. Br J Anaesth. 2004 Jan;92(1):78-88. doi: 10.1093/bja/aeh023.
- Background: PubMed 9066329Khine HH, Corddry DH, Kettrick RG, Martin TM, McCloskey JJ, Rose JB, Theroux MC, Zagnoev M. Comparison of cuffed and uncuffed endotracheal tubes in young children during general anesthesia. Anesthesiology. 1997 Mar;86(3):627-31; discussion 27A. doi: 10.1097/00000542-199703000-00015.
- Background: PubMed 20560884Eschertzhuber S, Salgo B, Schmitz A, Roth W, Frotzler A, Keller CH, Gerber AC, Weiss M. Cuffed endotracheal tubes in children reduce sevoflurane and medical gas consumption and related costs. Acta Anaesthesiol Scand. 2010 Aug;54(7):855-8. doi: 10.1111/j.1399-6576.2010.02261.x. Epub 2010 Jun 15.
- Background: PubMed 23422795Mehta SP, Bhananker SM, Posner KL, Domino KB. Operating room fires: a closed claims analysis. Anesthesiology. 2013 May;118(5):1133-9. doi: 10.1097/ALN.0b013e31828afa7b.
- Background: PubMed 22444738Raman V, Tobias JD, Bryant J, Rice J, Jatana K, Merz M, Elmaraghy C, Kang DR. Effect of cuffed and uncuffed endotracheal tubes on the oropharyngeal oxygen and volatile anesthetic agent concentration in children. Int J Pediatr Otorhinolaryngol. 2012 Jun;76(6):842-4. doi: 10.1016/j.ijporl.2012.02.055. Epub 2012 Mar 23.
- Individual participant dataSharing planned: No
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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.
Jerrold Lerman, MD, FRCPC principal investigator
Women & Children's Hospital of Buffalo
Questions about this trial
What is this clinical trial studying?
A study testing oxygen concentration, nitrous oxide concentration and carbon dioxide concentration in people with Exposure to Environmental Pollution and Adverse Effect of Unspecified General Anesthetic, run by State University of New York at Buffalo.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in the oxygen concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725164, which also lists 5 linked publications.
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 13 Feb 2017.