- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07590739
Effect Of Left Head Rotation On Glottic View During Video Laryngoscopy In Obese Adults (LeHeR)
Effect of Left Head Rotation Manoeuvre on Glottic View as Assessed With Percentage of Glottic Opening (POGO) Score During Video Laryngoscopy in Obese Adult Patients: A Prospective Observational Study
This study aims to evaluate whether the Left Head Rotation (LeHeR) maneuver improves visualization of the vocal cords during video laryngoscopy in obese adult patients undergoing general anesthesia. Obesity is associated with increased difficulty in airway management due to excess upper airway soft tissue and altered anatomy, which may impair visualization during intubation.
In this prospective observational study, 50 adult patients with a body mass index (BMI) ≥30 kg/m² will undergo video laryngoscopy using a C-MAC D-blade. The glottic view will be assessed using the Percentage of Glottic Opening (POGO) score in the standard sniffing position and after rotating the head 45 degrees to the left (LeHeR maneuver). A difference in POGO score between the two positions will be analyzed.
Secondary outcomes include ease of intubation, number of attempts, time to successful intubation, and occurrence of complications such as desaturation or airway trauma. The study is expected to determine whether the LeHeR maneuver is a simple and effective technique to improve airway visualization in obese patients.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Kalesh Divakar, MD
- Telefonnummer: +968 92452839
- E-mail: drkalesh@gmail.com
Undersøgelse Kontakt Backup
- Navn: Harihar V Hegde, MD
- Telefonnummer: +968 98845606
- E-mail: drharryhegde@yahoo.co.in
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria
- Adult patients aged 18-65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I-III
- Scheduled for elective surgical procedures under general anesthesia requiring endotracheal intubation
Exclusion Criteria:
- Anticipated need for nasal intubation
- Facial or upper airway pathology preventing laryngoscope insertion
- Cervical spine instability or contraindication to head movement
- Pregnant patients
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Percentage of Glottic Opening (POGO) Score between Sniffing Position and Left Head Rotation
Tidsramme: Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
The Percentage of Glottic Opening (POGO) score will be assessed during video laryngoscopy in the sniffing position and after 45-degree left head rotation (LeHeR maneuver).
The difference in POGO score between the two positions will be recorded for each participant.
|
Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Successful Intubation
Tidsramme: During induction of anesthesia on Day 1
|
Time taken from insertion of the video laryngoscope blade into the oral cavity until successful placement of the endotracheal tube confirmed by capnography.
|
During induction of anesthesia on Day 1
|
|
Ease of Intubation
Tidsramme: During tracheal intubation on Day 1
|
Ease of intubation assessed using Fremantle score as easy, modified, or unachievable based on number of attempts and need for adjuncts.
|
During tracheal intubation on Day 1
|
|
Number of Intubation Attempts
Tidsramme: During tracheal intubation on Day 1
|
Number of attempts required to achieve successful tracheal intubation.
|
During tracheal intubation on Day 1
|
|
Requirement of Airway Adjuncts
Tidsramme: During tracheal intubation on Day 1
|
Need for additional maneuvers such as external laryngeal manipulation, cuff inflation, or use of Magill forceps during intubation.
|
During tracheal intubation on Day 1
|
|
Incidence of Peri-intubation Complications
Tidsramme: During induction of anesthesia and tracheal intubation on day 1
|
Occurrence of complications such as oxygen desaturation (SpO₂ <95%) or airway trauma during intubation.
|
During induction of anesthesia and tracheal intubation on day 1
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MoH/CSR/26/31800
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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