Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty
Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations
1 other identifier
interventional
132
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedDecember 4, 2018
December 1, 2018
5 months
June 19, 2018
December 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 mounth
Secondary Outcomes (1)
emergence agitation
1 mounth
Study Arms (2)
Group SA
ACTIVE COMPARATORGroup SA intubated with Suction Above Cuff Endotracheal Tube
Group C
NO INTERVENTIONGroup C intubated with classic endotracheal tube
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients who will undergo rhinoplasty surgery,
- American Society of Anesthesiologists (ASA) I-II patients,
- Aged 18-65 years
You may not qualify if:
- 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,
- gastroesophageal reflux or sleep apnea,
- electrolyte disturbances such as hypomagnesemia and hypocalcemia,
- a BMI (body mass index) over 30 were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, 65080, Turkey (Türkiye)
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, Turkey (Türkiye)
Related Publications (4)
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.
PMID: 27788682RESULTCarter 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.
PMID: 24270899RESULTAlalami 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.
PMID: 18315632RESULTYuzkat 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.
PMID: 31114211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nureddin Yüzkat, Assis prof
Yuzuncu Yil University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
June 19, 2018
First Posted
July 12, 2018
Study Start
June 1, 2018
Primary Completion
October 30, 2018
Study Completion
October 30, 2018
Last Updated
December 4, 2018
Record last verified: 2018-12