Respiration and The Airway With Laryngeal Masks

NCT03542890 | Completed DMC

• 1 other identifier: BM2008
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Baska® mask (Proact Medical Systems, Frenchs Forest NSW, Australia) is displayed in figure 1 which is the latest addition to an array of supra-glottic airway devices in clinical use. It has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff over inflation, a known complication with other supraglottic airways. However, the cuff differs from other non-inflatable cuffs in that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation ,the cuff itself is inflated which may improve the seal so reducing leak and make ventilation more efficient. The Baska mask has two ports (one for venting and other for gastric tube insertion ), so it incorporates an inlet that fits into the upper oesophagus and the dorsal surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and towards the side channels to which suction can be attached to facilitate aspiration of this space. These features may reduce the risk of pulmonary aspiration of secretions or gastric contents that accumulate in the supraglottic area. In addition, there is integrated bite-block, which reduces the risk of patients biting and blocking the airway. There is insertion tab which is an extended hand-tab attached to the cuff that permits the operator to control the degree of flexion of the device during the insertion. The Baska® mask is inserted in the neutral head position, which may reduce the need for neck manipulation. Initial experience with Baska®mask has demonstrated it to be a suitable airway device for procedures less than 2 hours or when endotracheal intubation is not required. I-gel airway (Intersurgical Ltd, Workingham, Berkshire,United Kingdom) is displayed in figure 2 which is second generation supraglottic airway devices (SADs) that was introduced in 2007. The I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for gastric tube insertion. It is a latex free device that does not require digital insertion into mouth of patient. With an epiglottic rest and wider and shorter stem, the I-gel gives an optimal view of the glottis with a fiber- optic scope so a shorter tube is ideal for endotracheal tube placement. Moreover, I-gel can be inserted as fast as classic LMA (Laryngeal Mask Airway) with adequate ventilation in patients and has no major airway complications. Therefore, it could be a good alternative to classic LMA in emergency airway management or general anesthesia.

Conditions

Supraglottic Airway Devices

Keywords

Anesthesia, General; Baska; I-gel

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure

  The airway sealing pressure was the pressure at which leak starts. This leak pressure was calculated as the plateau airway pressure reached while the patient was apneic, and following confirmation of adequate ventilation, the adjustable pressure limit valve was set at 70 cmH2O, the fresh gas flow was set at 6 l.min-1(liter per minute), and the airway pressure was measured on the breathing system pressure gauge. Leak pressure will be defined as the plateau airway pressure that was achieved

  one year

Study Arms (2)

Baska Mask

It has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff over inflation, a known complication with other supraglottic airways.

Device: Baska Mask

I-gel

The I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for gastric tube insertion. It is a latex free device that does not require digital insertion into mouth of patient.

Device: I-gel

Interventions

Baska Mask DEVICE

used in adult low risk females undergoing elective gynecological operations

Baska Mask

I-gel DEVICE

used in adult low risk females undergoing elective gynecological operations

I-gel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

adult female patients undergoing elective gynecological operations.

You may qualify if:

• Adult female patients ASA I\&II
• Age: 18- 45 years old
• BMI \< 35
• Undergoing elective gynecological operations.

You may not qualify if:

• Patients with history of upper respiratory tract infections and obstructive sleep apnea.
• Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
• Patients with El-Ganzouri airway score ≥ 5 will.

Sponsors & Collaborators

• Reham Ali Abdelhaleem Abdelrahman: lead

Study Sites (1)

Department of Anesthesia, Surgical ICU, and Pain Management

Cairo, 11562, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesia Lecturer

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 31, 2018
• Study Start: June 14, 2018
• Primary Completion: July 8, 2021
• Study Completion: August 10, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

EG (1)