Perioperative HypothermiaLMA-HYPOTHNCT07913841
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
A study testing i-gel Supraglottic Airway Device and Endotracheal Tube in people with Perioperative Hypothermia and Hernia, Inguinal, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
Trial summary
This study aims to compare the effects of a laryngeal mask airway (i-gel) and an endotracheal tube on perioperative hypothermia in patients undergoing laparoscopic inguinal hernia surgery. The primary outcome is the incidence of hypothermia, defined as a core body temperature below 36°C, at the end of surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perioperative Hypothermia, Hernia, Inguinal
- What is being tested?
- i-gel Supraglottic Airway Device and Endotracheal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years.
- Male or female.
- Scheduled for elective laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Body mass index (BMI) between 18 and 30 kg/m².
- Willing to undergo general anesthesia.
- Providing written informed consent to participate in the study.
Who cannot join
- Requirement for emergency surgery.
- ASA physical status IV or higher.
- BMI below 18 kg/m² or above 30 kg/m².
- Known upper airway anatomical abnormalities or a history of difficult airway management.
- High risk of aspiration.
- Known esophageal disease or gastric emptying disorder.
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- History of malignant hyperthermia.
- Baseline core body temperature below 36°C or above 37.5°C.
- Active infection or fever in the preoperative period.
- Thyroid disease or endocrine/metabolic disorders that may significantly affect body temperature.
- Use of medications that may affect perioperative body temperature.
- Communication or cognitive impairment that may prevent adherence to the study protocol.
- Unplanned additional surgical procedures during surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Laryngeal Mask and Endotracheal Tube Use on Perioperative Hypothermia in Laparoscopic Inguinal Hernia Surgery: A Randomized Controlled Study
This study aims to compare the effects of a laryngeal mask airway (i-gel) and an endotracheal tube on perioperative hypothermia in patients undergoing laparoscopic inguinal hernia surgery. The primary outcome is the incidence of hypothermia, defined as a core body temperature below 36°C, at the end of surgery. The study will also evaluate perioperative temperature changes and relevant postoperative outcomes between the two airway management groups.
Read the detailed description
Perioperative hypothermia is a common concern during general anesthesia and surgery. Maintaining normothermia is important for patient safety and postoperative recovery. Airway management techniques may be associated with differences in perioperative heat loss; however, their effects on body temperature in patients undergoing laparoscopic inguinal hernia surgery require further investigation.
This study is designed to compare the effects of a laryngeal mask airway (i-gel) and an endotracheal tube on perioperative hypothermia in patients undergoing laparoscopic inguinal hernia surgery under general anesthesia.
Eligible patients will be allocated to one of two groups according to the airway management technique: the i-gel group or the endotracheal tube group. Perioperative body temperature will be monitored, and the incidence of hypothermia, defined as a core body temperature below 36°C at the end of surgery, will be assessed as the primary outcome.
Additional perioperative and postoperative outcomes, including changes in body temperature and the occurrence and severity of shivering, will be evaluated and compared between the groups.
The findings may help clarify whether the choice of airway management device is associated with differences in perioperative temperature regulation in patients undergoing laparoscopic inguinal hernia surgery.
- Conditions
- Perioperative Hypothermia, Hernia, Inguinal
- Being tested
- i-gel Supraglottic Airway Device, Endotracheal Tube
- Keywords
- Perioperative Hypothermia, Laparoscopic Inguinal Hernia Surgery, Endotracheal Tube, Laryngeal Mask Airway, Postoperative Shivering
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gel Supraglottic Airway DeviceDevice
Use of an i-gel supraglottic airway device for airway management during general anesthesia in laparoscopic inguinal hernia surgery.
Endotracheal TubeDevice
Use of an endotracheal tube for airway management during general anesthesia in laparoscopic inguinal hernia surgery.
| Study group | Role | What they receive |
|---|---|---|
| i-gel Group | Experimental | Patients will undergo general anesthesia with an i-gel supraglottic airway device for airway management during laparoscopic inguinal hernia surgery. Perioperative body temperature will be monitored, and the incidence of hypothermia will be assessed. Receives: Device: i-gel Supraglottic Airway Device |
| Endotracheal Tube Group | Experimental | Patients will undergo general anesthesia with an endotracheal tube for airway management during laparoscopic inguinal hernia surgery. Perioperative body temperature will be monitored, and the incidence of hypothermia will be assessed. Receives: Device: Endotracheal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Perioperative Hypothermia at the End of Surgery
The proportion of patients with a core body temperature below 36°C at the end of surgery will be compared between the i-gel and endotracheal tube groups.
Measured: At the end of surgery
Secondary outcomes (2)
Change in Core Body Temperature During Surgery
Perioperative changes in core body temperature will be compared between the i-gel and endotracheal tube groups.
Measured: From the beginning to the end of surgery
Incidence and Severity of Postoperative Shivering
The incidence and severity of postoperative shivering will be assessed and compared between the two groups. Shivering severity will be graded as none, mild, moderate, or severe.
Measured: During the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups comparing i-gel and endotracheal tube airway management
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yamac, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Dilek Yamac, MD, Study chair, Sultan 2. Abdulhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913841
- Sponsor's protocol ID
- SBU-ANESTEZİ-DMY-07
- Acronym
- LMA-HYPOTH
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laryngeal Mask and Endotracheal Tube Use on Perioperative Hypothermia in Laparoscopic Inguinal Hernia Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07913841
- Acronym / sponsor ID
- LMA-HYPOTH / SBU-ANESTEZİ-DMY-07
- Conditions
- Perioperative Hypothermia, Hernia, Inguinal
- Keywords
- Perioperative Hypothermia, Laparoscopic Inguinal Hernia Surgery, Endotracheal Tube, Laryngeal Mask Airway, Postoperative Shivering
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effects of a laryngeal mask airway (i-gel) and an endotracheal tube on perioperative hypothermia in patients undergoing laparoscopic inguinal hernia surgery. The primary outcome is the incidence of hypothermia, defined as a core body temperature below 36°C, at the end of surgery. The study will also evaluate perioperative temperature changes and relevant postoperative outcomes between the two airway management groups.
Detailed description
Perioperative hypothermia is a common concern during general anesthesia and surgery. Maintaining normothermia is important for patient safety and postoperative recovery. Airway management techniques may be associated with differences in perioperative heat loss; however, their effects on body temperature in patients undergoing laparoscopic inguinal hernia surgery require further investigation.
This study is designed to compare the effects of a laryngeal mask airway (i-gel) and an endotracheal tube on perioperative hypothermia in patients undergoing laparoscopic inguinal hernia surgery under general anesthesia.
Eligible patients will be allocated to one of two groups according to the airway management technique: the i-gel group or the endotracheal tube group. Perioperative body temperature will be monitored, and the incidence of hypothermia, defined as a core body temperature below 36°C at the end of surgery, will be assessed as the primary outcome.
Additional perioperative and postoperative outcomes, including changes in body temperature and the occurrence and severity of shivering, will be evaluated and compared between the groups.
The findings may help clarify whether the choice of airway management device is associated with differences in perioperative temperature regulation in patients undergoing laparoscopic inguinal hernia surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two parallel groups comparing i-gel and endotracheal tube airway management
| Arm | Type | Receives |
|---|---|---|
| i-gel Group | Experimental | Device: i-gel Supraglottic Airway DevicePatients will undergo general anesthesia with an i-gel supraglottic airway device for airway management during laparoscopic inguinal hernia surgery. Perioperative body temperature will be monitored, and the incidence of hypothermia will be assessed. |
| Endotracheal Tube Group | Experimental | Device: Endotracheal TubePatients will undergo general anesthesia with an endotracheal tube for airway management during laparoscopic inguinal hernia surgery. Perioperative body temperature will be monitored, and the incidence of hypothermia will be assessed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-65 years.
- Male or female.
- Scheduled for elective laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Body mass index (BMI) between 18 and 30 kg/m².
Key exclusion criteria (13 listed)
- Requirement for emergency surgery.
- ASA physical status IV or higher.
- BMI below 18 kg/m² or above 30 kg/m².
- Known upper airway anatomical abnormalities or a history of difficult airway management.
- High risk of aspiration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-gel Supraglottic Airway DeviceUse of an i-gel supraglottic airway device for airway management during general anesthesia in laparoscopic inguinal hernia surgery. | Device | i-gel Group |
| Endotracheal TubeUse of an endotracheal tube for airway management during general anesthesia in laparoscopic inguinal hernia surgery. | Device | Endotracheal Tube Group |
Primary outcome
Incidence of Perioperative Hypothermia at the End of Surgery
Time frame: At the end of surgery
The proportion of patients with a core body temperature below 36°C at the end of surgery will be compared between the i-gel and endotracheal tube groups.
2 secondary outcomes
Change in Core Body Temperature During Surgery
Time frame: From the beginning to the end of surgery
Incidence and Severity of Postoperative Shivering
Time frame: During the postoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Goal-Directed Temperature Management During Prolonged Abdominal Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dilek Yamac, MD study chair
Sultan 2. Abdulhamid Han Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing i-gel Supraglottic Airway Device and Endotracheal Tube in people with Perioperative Hypothermia and Hernia, Inguinal, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek M Metin Yamac, MD (+905054959792, ddilekmetin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Perioperative Hypothermia at the End of Surgery (time frame: At the end of surgery). 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 3 Nov 2026.