Clinical trial NCT03584503: Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty
Official title: Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinoplasty
Keywords: general anesthesia
laryngospasm
postoperative complications
rhinoplasty
Suction Above Cuff Endotracheal Tube
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized prospective controlled study
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who will undergo rhinoplasty surgery,
* American Society of Anesthesiologists (ASA) I-II patients,
* Aged 18-65 years

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of laryngospasm
timeFrame: 1 mounth
Secondary outcomes:
measure: emergence agitation
timeFrame: 1 mounth
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van yuzuncu Yıl University, Dursun Odabas Medical Center
city: Van
country: Turkey
facility: Van yuzuncu Yıl University, Dursun Odabas Medical Center
Study officials:
affiliation: Yuzuncu Yıl University
name: Nureddin Yüzkat, Assis prof
role: STUDY_CHAIR
References:
citation: 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.
citation: Carter 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.
citation: Alalami 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.
citation: Yuzkat 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.