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AnaesthesiaNCT02125838

Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery

A study testing Laryngeal Mask Airway-Supreme and Endotracheal Tube in people with Anaesthesia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Laryngeal mask (LM) use in gynecological laparoscopy, contrary to widespread opinion, does not increase the incidence of gastric aspiration, the failure of ventilation or the risk of pulmonary aspiration . Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Anaesthesia
What is being tested?
Laryngeal Mask Airway-Supreme and Endotracheal Tube
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
May 2013to Apr 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA classification group I-II
  • Between 18-65 years
  • Undergoing elective laparoscopic gynecological surgery

Who cannot join

  • Individuals with any neck and upper respiratory pathology
  • Individuals at risk of gastric content regurgitation/aspiration (previous upper gastrointestinal surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
  • Individuals with low pulmonary compliance or high airway resistance (chronic lung diseases)
  • Obese patients (BMI >35)
  • Individuals with sore throat, dysphagia and dysphonia
  • Individuals with possibility or history of difficult airway
  • Operation time planned for more than 4 hours

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sule Ozbilgin

    Izmi̇r, Narlıdere, 35320

Other trials in Turkey (Türkiye)

About this study

Official title: Application of Endotracheal Intubation and Laryngeal Mask Supreme Without Neuromuscular Blocker in Laparoscopic Gynecologic Surgery

Laryngeal mask (LM) use in gynecological laparoscopy, contrary to widespread opinion, does not increase the incidence of gastric aspiration, the failure of ventilation or the risk of pulmonary aspiration . LM is presented as an alternative to endo tracheal tube (ETT) in spontaneous or positive pressure ventilation (PPV) . LM has gained widespread popularity in England for gynecological laparoscopic procedures. In addition in many previous studies LM has been successfully shown to provide appropriate lung ventilation in laparoscopic surgical interventions .Miller et al. compared the use of ETT, LM-P laparoscopic gynecological interventions and identified advantages to LM use. The most important of these advantages was that, contrary to tracheal tube techniques for laparoscopic surgeries, use of supraglottic laryngeal devices or neuromuscular blocker agents (NBA) were not required during placement. Thus for laparoscopic surgeries, compared with the ETT technique, without the need for supraglottic laryngeal devices or muscular relaxants, it is easily placed and reduces the time spent in the operating room.

Our aim; to compare the use of LM-S and ETT without neuromuscular agents for laparoscopic gynecological intervention with positive pressure ventilation from a surgical viewpoint and in terms of effect on ventilation parameters.

Secondary aim, comparison of airway morbidity with endotracheal intubation and supraglottic.

Read the detailed description

This prospective, randomized and double-blind study received permission from "Dokuz Eylül University Medical Faculty Non-Interventional Research Ethics Committee" and after obtaining patients' informed consent, 100 patients with American society of anesthesiologists (ASA) classification group I-II, between 18-65 years, undergoing elective laparoscopic gynecological surgery were included.

Patients were divided into:

Group 1=>ETT (50 patients) Group 2=>LM-S (50 patients) Patients and surgeons performing the operation were not aware of which airway device was used. The patients in the groups were determined by block randomized methods.

Patients taken to the surgical room were given standard monitoring (non-invasive blood pressure measurements, electrocardiogram, and peripheral oxygen saturation measurements) before anesthesia induction. For preoperative sedation 0.02 mg/kg midazolam IV was administered.

Patients were preoxygenated with 6 L/min oxygen for 3 minutes through a face mask.

For anesthesia induction after 2 minutes of 0.2 µg/kg/min remifentanil and 6 mg/kg/hr propofol infusion, IV 1-2 mg/kg propofol was administered. After induction patients were ventilated with 6 L/min 100% fraction of inspired oxygen inspired oxygen fraction oxygen through a face mask. Anesthesia depth was standardized in all patients using bispectral index monitoring. Bispectral index values were held between 40-60. Bispectral index values were maintained in this interval by increasing or decreasing propofol infusion by 1 mg/kg.

Airway devices were inserted by two researchers with more than 5 years experience.

During airway device placement according to patient reactions an extra dose of 0.5 mg/kg propofol was given if necessary.

Anesthetic maintenance was provided by 50% O2/air mixture with 0.1-0.4 µg/kg/min remifentanil and 50-150 µg/kg/hr (3-9 mg/kg/hr) propofol IV infusion.

Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.

After LM-S placement the cuff was inflated with air so as to have a pressure below 60 centimeters of water (cuff pressure manometer, Rusch, Germany). Two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal, cuff pressure was measured repeatedly and recorded. At the same time intervals in the ETT group, ETT cuff pressure was measured.

In the ETT group for women no. 7-7.5 tube was used. The ETT cuff was inflated until the leak sound ceased. It was measured with a manometer to remain between 20-30 centimeters of water.

Successful placement of LM or ETT was confirmed by square-shaped waves observed on the capnogram, easy ventilation of the respiration balloon and visible chest movements. After successful placement of the airway device, it was covered to prevent observation of which device was used.

The length of time for successful placement (duration from mouth opening to first successful ventilation), number of tries, and ease of placement were recorded. Ease of placement was evaluated by the anesthetist in charge of the airway as easy, hard or unsuccessful (alternative airway management).

In a situation where airway provision was unsuccessful after 3 tries, patients without placement of LM-S or who could not be intubated were switched to the other group and airway management was provided.

For oropharyngeal leak test after the expiratory valve was closed air was shut off, O2 was reduced to 3 L/min and the first pressure value when a leak sound was heard was recorded as the oropharyngeal leak pressure. To prevent exposure of the lungs to barotrauma, when the peak inspiratory pressure reached 40centimeters of water the expiratory valve was opened and the test was concluded. This test was repeated before peritoneal insufflation, 10 minutes later and immediately before desufflation and was completed by a researcher blind to the type of airway device inserted.

Positive pressure respiration was begun by using a ring system, 2-4 L/min fresh gas flow and 0.5 volume controlled 6-8 ml/kg tidal volume and 10 respirations/min frequency. Positive end expiratory pressure was not administered and I:E ratio was adjusted to 1:2. ETCO2 was held between 35-45 mmHg, if necessary first respiration frequency was increased then tidal volume was increased. Permission was given for CO2 insufflation for the laparoscopic intervention with peritoneal interior pressure of 15 mmHg.

Two minutes after LM-S or ETT placement, before insufflation, 10 minutes after insufflation and trendelenburg position, immediately before peritoneal desufflation and before airway device removal, ventilation parameters were evaluated.

Respiratory measurements to be recorded: Tidal volume (TV), respiration number (RN), peripheral oxygen saturation (SPO2), end-tidal carbon dioxide pressure (PETCO2), peak airway pressure (P peak), mean airway pressure (P mean) and expiration volume per minute (VE).

Hemodynamic measurements to be recorded: (simultaneous to the measurements above and additionally before induction) Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP) and heart rate (HR).

Evaluation related to gastric tube:

Immediately after airway device placement using either the LM-S drainage tube or in intubated patients using a 14 F orogastric probe within the airway, the stomach was reached and the gastric contents were aspirated. Ease of placement and amount of fluids aspirated were recorded. Ease of placement was classified by the person who inserted the orogastric probe as very easy, easy, difficult and very difficult.

The number of interventions with Verres needle, initial intra-abdominal pressure, duration to reach intra-abdominal pressure of 15 mmHg, and insufflated volume of CO2 were recorded. Sufficiency of pneumoperitoneum (sufficient/insufficient), and quality of airway provision were evaluated by the surgeon who was blind to the airway device used by giving points between 1-4.

Immediately after the intra-abdominal laparoscopic intervention and immediately before peritoneal insufflation was ended, gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field) and the difference between the scores at the start and end of the operation was recorded.

When the patient cooperated LM-S or ETT was removed and total anesthesia duration and peritoneal insufflation duration was recorded. Possible complications that could develop during airway device removal (coughing, vomiting, laryngeal stridor, laryngeal spasm or requirement for airway intervention) were recorded.

After laryngeal supra glottic airway device removal the presence of blood was evaluated as

  1. no blood
  2. trace amounts of blood
  3. clear amount of blood Revived patients were taken to the recovery unit and a blind researcher evaluated the patients' throat pain, hoarseness and presence of difficulty swallowing in the 1st and 24th hours. To evaluate throat pain the visual analogue scale was used.
Conditions
Anaesthesia
Being tested
Laryngeal Mask Airway-Supreme, Endotracheal Tube
Keywords
laryngeal mask Supreme, laparoscopic gynecologic surgery, Laryngeal mask during surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laryngeal Mask Airway-SupremeDevice

    Also called Group LM-S

    Group LM-S (Laryngeal Mask Airway-Supreme)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.

  • Endotracheal TubeDevice

    Also called Group ETT

    ETT

Study groups in NCT02125838
Study groupRoleWhat they receive
Group ETTActive comparatorGroup endotracheal tube In the endotracheal tube group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Sdn. Bhd. Malaysia. Ref:112482
Receives: Device: Endotracheal Tube
Group LMSExperimentalLaryngeal mask airway-supreme Group In the LMS group for <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
Receives: Device: Laryngeal Mask Airway-Supreme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asses to Ventilation Parameters

    tidal volume (ml) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device

    Measured: intraoperative period

  2. Asses to Peak Pressure

    peak pressure (cmH20) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device

    Measured: intraoperative period

  3. Asses to Mean Pressure

    mean pressures within the times below (cmH20) T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device

    Measured: during procedure

Secondary outcomes (5)
  1. Quality of View According to Surgeon by Rate Scale

    Quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device by Rate Scale.

    Grade of quality of view were evaluated between 1-4 points (1-poor to 4-excellent)

    Measured: intraoperative period

  2. Evaluation of Gastric Distention

    To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)

    Measured: Baseline

  3. Ease of Orogastric Tube Placement Classification

    Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.

    Measured: Baseline

  4. Haemodynamic Response to Insertion of Airway Device

    Systolic blood pressure and heart rate at two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal .

    Measured: Baseline

  5. Incidence of Post-operative Sore Throat

    Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr and 24 hr after the end of surgery.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2014 (estimated)
  2. Study startMay 2013
  3. Primary completionMar 2015
  4. Study completionApr 2015

Resources

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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02125838
Sponsor's protocol ID
859-GOA
Status last verified
Feb 2017
First submitted
31 Jan 2014
Last updated
28 Mar 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Laryngeal Mask Airway-Supreme and Endotracheal Tube in people with Anaesthesia, run by Dokuz Eylul University at 1 site 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 7 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Asses to Ventilation Parameters (time frame: intraoperative period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Mar 2017.

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