RhinoplastyNCT03584503
Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty
A study testing Suction Above Cuff Endotracheal Tube in people with Rhinoplasty, run by Yuzuncu Yil University at 2 sites in Turkey (Türkiye).
Trial summary
Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoplasty
- What is being tested?
- Suction Above Cuff Endotracheal Tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 30 Oct 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo rhinoplasty surgery,
- American Society of Anesthesiologists (ASA) I-II patients,
- Aged 18-65 years
Who cannot join
- Patients who had upper or lower respiratory tract infections,
- asthma,
- a history of allergy,
- who received isoflurane and desflurane for maintenance of anesthesia,
- who were the ASA class III-IV,
- and who had a long uvula,
Show all 9Show fewer
- gastroesophageal reflux or sleep apnea,
- electrolyte disturbances such as hypomagnesemia and hypocalcemia,
- a BMI (body mass index) over 30 were excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, 65080
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van
About this study
Official title: Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations
Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, we aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations. This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty.
The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.
Read the detailed description
Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, the investigators aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations.
This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty. The patients were randomly divided into 2 groups: Suction Above Cuff Endotracheal Tube (n:66) (Group SA) and classic endotracheal tube (n:66) (Group C). Complications following general anesthesia were statistically analyzed among the two groups.
55 male patients and 77 female patients were included in the study. The incidences of postoperative laryngospasm and respiratory complications were found to be lower in Group SA compared to Group C. In addition, the incidences of agitation, postoperative nausea and vomiting (PONV), swallowing difficulty, and sore throat were found to be lower in Group SA compared to Group C. However, the incidences of cough, hypotension, and tachycardia were similar in both groups. No PONV, swallowing difficulty, and hypotension were observed in Group SA. The blood volume accumulated in the suction chamber was found to be greater in Group SA compared to Group C.
The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.
- Conditions
- Rhinoplasty
- Being tested
- Suction Above Cuff Endotracheal Tube
- Keywords
- general anesthesia, laryngospasm, postoperative complications, rhinoplasty, Suction Above Cuff Endotracheal Tube
- Medical subject headings
- Laryngismus, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction Above Cuff Endotracheal TubeOther
Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space
| Study group | Role | What they receive |
|---|---|---|
| Group SA | Active comparator | Group SA intubated with Suction Above Cuff Endotracheal Tube Receives: Other: Suction Above Cuff Endotracheal Tube |
| Group C | No intervention | Group C intubated with classic endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of laryngospasm
While the presence of findings such as apnea (an apneic event was counted by either documentation of apnea by nursing notes through visual observation or documented pauses ≥15 s), desaturation (peripheral oxygen saturation <85%) and inspiratory stridor (Stridor is a harsh, vibratory sound of variable pitch caused by partial obstruction of the respiratory passages that results in turbulent airflow through the airway) after extubation was considered as laryngospasm.
Measured: 1 mounth
Secondary outcomes (1)
emergence agitation
Riker Sedation-Agitation Scale Score ≥5 (7-Dangerous agitation: Pulling at endotracheal tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side 6- Very agitated: Does not calm despite frequent verbal reminding of limits, requires physical restraints, biting endotracheal tube 5- Agitated: Anxious or mildly agitated, attempting to sit up, calms down on verbal instructions 4- Calm cooperative: Calm, easily arousable, follows commands 3- Sedated: Difficult to arouse, awakens to verbal stimuli or gentle shaking but drifts off again, follows simple commands 2- Very sedated: Arouses to physical stimuli but does not communicate or follow commands, may move spontaneously
1- Unarousable: Minimal or no response to noxious stimuli, does not communicate or follow command)
Measured: 1 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RhinoplastyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized prospective controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nureddin YUZKAT, Yuzuncu Yil University
- Investigators
- Nureddin Yüzkat, Assis prof, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584503
- Sponsor's protocol ID
- SACETT
- Status last verified
- Dec 2018
- First submitted
- 19 Jun 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mao Z, Gao L, Wang G, Liu C, Zhao Y, Gu W, Kang H, Zhou F. Subglottic secretion suction for preventing ventilator-associated pneumonia: an updated meta-analysis and trial sequential analysis. Crit Care. 2016 Oct 28;20(1):353. doi: 10.1186/s13054-016-1527-7.
PubMed 27788682Carter EL, Duguid A, Ercole A, Matta B, Burnstein RM, Veenith T. Strategies to prevent ventilation-associated pneumonia: the effect of cuff pressure monitoring techniques and tracheal tube type on aspiration of subglottic secretions: an in-vitro study. Eur J Anaesthesiol. 2014 Mar;31(3):166-71. doi: 10.1097/EJA.0000000000000009.
PubMed 24270899Alalami AA, Ayoub CM, Baraka AS. Laryngospasm: review of different prevention and treatment modalities. Paediatr Anaesth. 2008 Apr;18(4):281-8. doi: 10.1111/j.1460-9592.2008.02448.x.
PubMed 18315632Yuzkat N, Demir CY. Effect of using the Suction Above Cuff Endotracheal Tube (SACETT) on postoperative respiratory complications in rhinoplasty: a randomized prospective controlled trial. Ther Clin Risk Manag. 2019 Apr 17;15:571-577. doi: 10.2147/TCRM.S200662. eCollection 2019.
PubMed 31114211
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations
- ClinicalTrials.gov ID
- NCT03584503
- Acronym / sponsor ID
- SACETT
- Conditions
- Rhinoplasty
- Keywords
- general anesthesia, laryngospasm, postoperative complications, rhinoplasty, Suction Above Cuff Endotracheal Tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 12 Jul 2018 (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.
Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, we aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations. This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty.
The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.
Detailed description
Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, the investigators aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations.
This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty. The patients were randomly divided into 2 groups: Suction Above Cuff Endotracheal Tube (n:66) (Group SA) and classic endotracheal tube (n:66) (Group C). Complications following general anesthesia were statistically analyzed among the two groups.
55 male patients and 77 female patients were included in the study. The incidences of postoperative laryngospasm and respiratory complications were found to be lower in Group SA compared to Group C. In addition, the incidences of agitation, postoperative nausea and vomiting (PONV), swallowing difficulty, and sore throat were found to be lower in Group SA compared to Group C. However, the incidences of cough, hypotension, and tachycardia were similar in both groups. No PONV, swallowing difficulty, and hypotension were observed in Group SA. The blood volume accumulated in the suction chamber was found to be greater in Group SA compared to Group C.
The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized prospective controlled study
| Arm | Type | Receives |
|---|---|---|
| Group SA | Active comparator | Other: Suction Above Cuff Endotracheal TubeGroup SA intubated with Suction Above Cuff Endotracheal Tube |
| Group C | No intervention | –Group C intubated with classic endotracheal tube |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will undergo rhinoplasty surgery,
- American Society of Anesthesiologists (ASA) I-II patients,
- Aged 18-65 years
Key exclusion criteria (9 listed)
- Patients who had upper or lower respiratory tract infections,
- asthma,
- a history of allergy,
- who received isoflurane and desflurane for maintenance of anesthesia,
- who were the ASA class III-IV,
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 |
|---|---|---|
| Suction Above Cuff Endotracheal TubeSuction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space | Other | Group SA |
Primary outcome
Incidence of laryngospasm
Time frame: 1 mounth
While the presence of findings such as apnea (an apneic event was counted by either documentation of apnea by nursing notes through visual observation or documented pauses ≥15 s), desaturation (peripheral oxygen saturation <85%) and inspiratory stridor (Stridor is a harsh, vibratory sound of variable pitch caused by partial obstruction of the respiratory passages that results in turbulent airflow through the airway) after extubation was considered as laryngospasm.
1 secondary outcome
emergence agitation
Time frame: 1 mounth
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 4 Dec 2018.
- Results publication: PubMed 27788682Mao Z, Gao L, Wang G, Liu C, Zhao Y, Gu W, Kang H, Zhou F. Subglottic secretion suction for preventing ventilator-associated pneumonia: an updated meta-analysis and trial sequential analysis. Crit Care. 2016 Oct 28;20(1):353. doi: 10.1186/s13054-016-1527-7.
- Results publication: PubMed 24270899Carter EL, Duguid A, Ercole A, Matta B, Burnstein RM, Veenith T. Strategies to prevent ventilation-associated pneumonia: the effect of cuff pressure monitoring techniques and tracheal tube type on aspiration of subglottic secretions: an in-vitro study. Eur J Anaesthesiol. 2014 Mar;31(3):166-71. doi: 10.1097/EJA.0000000000000009.
- Results publication: PubMed 18315632Alalami AA, Ayoub CM, Baraka AS. Laryngospasm: review of different prevention and treatment modalities. Paediatr Anaesth. 2008 Apr;18(4):281-8. doi: 10.1111/j.1460-9592.2008.02448.x.
- Derived from this study: PubMed 31114211Yuzkat N, Demir CY. Effect of using the Suction Above Cuff Endotracheal Tube (SACETT) on postoperative respiratory complications in rhinoplasty: a randomized prospective controlled trial. Ther Clin Risk Manag. 2019 Apr 17;15:571-577. doi: 10.2147/TCRM.S200662. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
Nureddin Yüzkat, Assis prof study chair
Yuzuncu Yil University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suction Above Cuff Endotracheal Tube in people with Rhinoplasty, run by Yuzuncu Yil University at 2 sites in Turkey (Türkiye).
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 9 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
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?
Incidence of laryngospasm (time frame: 1 mounth). 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 NCT03584503, which also lists 4 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 4 Dec 2018.