Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management Technique
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center
About this trial
Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to limiting emergence phenomena such as coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and tachycardia.
Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher ventilation pressures may be required, in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow the anesthesiologist to have little accessibility the airway.
The aim of this study is to investigate an airway management technique that would allow for the benefits of the ETT in terms of a secure airway for the duration of the surgical procedure as well the potential for less emergence phenomena seen when emerging with an LMA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA 1-3
Patients undergoing elective laparoscopic surgery
Disqualifiers
Individuals who cannot provide consent
Individuals who would require translation services to provide consent
Prisoners
Parturients
Trial design
Design model
Single group
Treatments tested in this trial
Induction of anesthesia
Procedure/SurgeryAt the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent
Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]
DeviceBy standard method. Sizing at the discretion of the primary anesthesiologist.
Laryngoscopy and placement of ETT
DeviceVia direct or indirect laryngoscopy. Sizing at the discretion of the primary anesthesiologist. Mallinckrodt (TM) Intermediate Hi-Lo cuffed endotracheal tube (Covidien)
Ventilation via the ETT
Procedure/SurgeryVentilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.
Removal of the ETT
Procedure/SurgeryEither upon emergence of anesthesia after suctioning of the oropharynx and after a positive pressure breath or while deeply anesthetized after release of the pneumoperitoneum in the combined LMA/ETT group.
Intubation of the trachea through the LMA
Procedure/SurgeryWith ETT using fiberoptic bronchoscope guidance.
Ventilation via the LMA
Procedure/SurgeryAfter removal of the ETT. Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.
Emergence from anesthesia
Procedure/SurgeryAt the discretion of primary team. Airway device (either ETT or LMA) will be removed when patient is adequately ventilating and able to respond to commands (such as "open your eyes" or "squeeze my hand").
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: ETT onlyActive comparator 5 interventions
Group B: Combined ETT/LMA techniqueExperimental treatment 7 interventions
Trial outcomes
Primary outcomes
1
Change in rate pressure product during emergence
Difference in heart rate multiplied by systolic blood pressure measured during the \~5 minutes prior to emergence and the \~5 minutes after removal of the airway device. Heart rate is continuously monitored and recorded at one minute intervals. Blood pressure is intermittently monitored at 3 minute intervals. The two SBPs measured prior to removal of the airway device will be multiplied by the HR at those times and the RPPs will be averaged. This will be compared with average of the product of the two SBPs and their corresponding HRs measured after removal of the airway device.
Time frame
IntraoperativeSecondary outcomes
1
Time to successful ventilation via ETT
From administration of induction medication until ETT placement confirmed via capnography.
Time frame
Intraoperative2
Change in rate pressure product during induction of anesthesia and intubation
Difference in heart rate multiplied by systolic blood pressure measured during the \~5 minutes prior to induction of anesthesia and the \~5 minutes after placement of the airway device. Heart rate is continuously monitored and recorded at one minute intervals. Blood pressure is intermittently monitored at 3 minute intervals. The two SBPs measured prior to placement of the airway device will be multiplied by the HR at those times and the RPPs will be averaged. This will be compared with average of the product of the two SBPs and their corresponding HRs measured after placement of the airway device.
Time frame
Intraoperative3
Success rate of ventilation with LMA after extubation of trachea
After deflation of the pneumoperitoneum, the ETT will be removed and ventilation will be continued through the LMA. Success will be graded as follows: 1. Adequate ventilation via LMA without need for adjustment. 2. Adequate ventilation via LMA after adjustment of LMA. 3. Inadequate ventilation via LMA. Unable to successfully re-seat LMA and need to re-intubate.
Time frame
Intraoperative4
Presence/ severity of cough during prior to removal of airway device
During 5 minutes prior to removal of airway device. Cough will be graded as follows: None Mild = 1 episode of unsustained coughing (\< 5 s) Moderate = More than 1 episode of unsustained (\<5 s) coughing Severe = Sustained bout(s) of coughing (\>5 s) http://www.ncbi.nlm.nih.gov/pubmed/15385385 - (5. Minogue 2004)
Time frame
IntraoperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
Ambu A/S
Collaborator
Source ClinicalTrials.gov