Comparison of Mask Ventilation in Obese Patients by Differents One Hand Techniques

NCT06817083 | Completed

• 1 other identifier: 964/9/24
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this controled clinical trial study to know if hook tecnique method is better than other traditional one hand ventilation methods in acheiving effective ventilation in obese patients . The main questions it aims to answer \[are\]: Primary Outcome Measures

• Chest Rise and Fall: This will be visually assessed by an independent observer. evaluation the techniques based on the chest expansion score from 1 to 4. To evaluate Chest Rising in the studied patients, by visual method, patients were categorized into four groups: the amount of chest rising in group one was between 0 and 25% (score 1), 25-50% in group two (score 2), 50-75% in group three (score 3) and 75-100% in group four (score 4). Patients in group one and two considered to have unsuccessful ventilation due to lack in chest rise, and in groups three and four, the ventilation was considered successful • Ultra-sounded guided diaphragmatic excursion: It will be considered successful ventilation if Diaphragmatic excursion more than 2 cm and will be considered ventilation failure if less than 2 cm • Oxygen Saturation: SpO2 levels will be continuously monitored using a pulse oximeter, with readings recorded at baseline (before ventilation) and at regular intervals (every 15 seconds) until effective ventilation is achieved or the 2-minute mark is reached.
• Measurement of Exhaled Tidal Volume: Determine if the Hook Technique provides superior tidal volume (mL/kg of predicted body weight) compared to the E-C and T-E techniques within the first 2 minutes of ventilation and will be consider successful ventilation if exhaled tidal volume more than 6 ml per kg and failure if less than 6 ml per kg
• Peak Inspiratory Pressure (PIP): Compare the peak inspiratory pressures generated during ventilation with each technique and will be consider failure of ventilation if more than 30 Lower PIP for a given tidal volume indicates more efficient ventilation, which is particularly important in obese patients who often require higher pressures due to increased airway resistance Secondary Outcome Measures
• Time to Achieve Effective Ventilation:
• The stopwatch will start as soon as the anesthesiologist initiates the ventilation technique.
• The time will be stopped when the criteria for effective ventilation (chest rise and fall, SpO2 ≥ 95%) are met.
• This measure provides an indication of the efficiency of each technique in rapidly achieving effective ventilation.
• Rate of Ventilation Attempts:
• Incidence of Ventilation Failure:
• Complications:

Conditions

Mask Ventilation; Obese Patients (BMI ≥ 30 kg/m²); Obesity & Overweight; Bag-mask Ventilation

Keywords

mask ventilation; Hook technique; Obesity; bag-mask ventilation

Outcome Measures

Primary Outcomes (1)

• Ventilation success,

  Chest rise score ≥3 on a validated 5-point scale (0 = no chest movement; 1 = minimal; 2 = slight; 3 = adequate; 4 = good; 5 = excellent) assessed by a blinded observer at 30 seconds.\[

  At time of enrollment

Secondary Outcomes (8)

• Time to Achieve Effective Ventilation Using the Hook Technique Versus E/C and T/E Techniques in Obese Patients

  At time of enrollment

• Number of Attempts Needed to Achieve Effective Ventilation Using the Hook Technique Versus E/C and T/E Techniques

  At time of enrollment

• Ease of use of the Hook Technique Compared to E/C and T/E Techniques as Rated by Anesthesiologists

  At time of enrollment

• Exhaled tidal volume (ETV, mL):

  From enrollment to the end of study at 12 months

• Peak inspiratory pressure (PIP, cmH₂O)

  At time of enrollment

Study Arms (3)

Group Hook technique

ACTIVE COMPARATOR

novel method for single-hand ventilation that has shown promise in preliminary studies. This technique involves a unique hand positioning that aims to improve mask seal and ventilation efficacy, particularly in patients with challenging airway anatomy. In Hook Technique using the thumb and index finger to form a hook around the mask, creating a more secure and adjustable seal and utilizing the remaining fingers to apply consistent mandibular lift

Procedure: The Hook Technique

Group E&c technique

ACTIVE COMPARATOR

E-C clamp technique involves forming a "C" with the thumb and index finger around the mask while the remaining fingers form an "E" to lift the mandible. This technique aims to provide a good seal while opening the airway.

Procedure: E-C Clamp Technique

Group T&E

ACTIVE COMPARATOR

T-E technique is a variation where the thumb and index finger form a "T" over the mask while the other fingers provide chin lift and jaw thrust. This method is designed to optimize airway patency and mask seal. While these techniques are widely taught and practiced, they often fall short in obese patients due to the difficulty in maintaining an adequate seal and achieving sufficient ventilation pressures. Complications such as hypoxemia and gastric insufflation are more common in this population

Procedure: T-E Technique

Interventions

E-C Clamp Technique PROCEDURE

The E-C clamp technique involves forming a "C" with the thumb and index finger around the mask while the remaining fingers form an "E" to lift the mandible. This technique aims to provide a good seal while opening the airway.

Group E&c technique

T-E Technique PROCEDURE

The T-E technique is a variation where the thumb and index finger form a "T" over the mask while the other fingers provide chin lift and jaw thrust. This method is designed to optimize airway patency and mask seal. While these techniques are widely taught and practiced, they often fall short in obese patients due to the difficulty in maintaining an adequate seal and achieving sufficient ventilation pressures. Complications such as hypoxemia and gastric insufflation are more common in this population.

Group T&E

The Hook Technique PROCEDURE

e is a novel method for single-hand ventilation that has shown promise in preliminary studies. This technique involves a unique hand positioning that aims to improve mask seal and ventilation efficacy, particularly in patients with challenging airway anatomy. In Hook Technique using the thumb and index finger to form a hook around the mask, creating a more secure and adjustable seal and utilizing the remaining fingers to apply consistent mandibular lift, enhancing airway patency.

Group Hook technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• bmi \> 30

You may not qualify if:

• bmi\>40

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

Location

Related Publications (3)

• Fei M, Blair JL, Rice MJ, Edwards DA, Liang Y, Pilla MA, Shotwell MS, Jiang Y. Comparison of effectiveness of two commonly used two-handed mask ventilation techniques on unconscious apnoeic obese adults. Br J Anaesth. 2017 Apr 1;118(4):618-624. doi: 10.1093/bja/aex035.

  PMID: 28403406 BACKGROUND

• Soleimanpour M, Rahmani F, Ala A, Morteza Bagi HR, Mahmoodpoor A, Golzari SE, Zahmatyar F, Mehdizadeh Esfanjani R, Soleimanpour H. Comparison of four techniques on facility of two-hand Bag-valve-mask (BVM) ventilation: E-C, Thenar Eminence, Thenar Eminence (Dominant hand)-E-C (non-dominant hand) and Thenar Eminence (non-dominant hand) - E-C (dominant hand). J Cardiovasc Thorac Res. 2016;8(4):147-151. doi: 10.15171/jcvtr.2016.30. Epub 2016 Dec 27.

  PMID: 28210469 BACKGROUND

• Balafar M, Pouraghaei M, Paknezhad SP, Abad SNA, Soleimanpour H. Evaluation the quality of bag-mask ventilation by E/C, T/E and hook technique (a new proposed technique). BMC Anesthesiol. 2023 Nov 23;23(1):384. doi: 10.1186/s12871-023-02349-w. Erratum In: BMC Anesthesiol. 2024 Apr 25;24(1):160. doi: 10.1186/s12871-024-02545-2.

  PMID: 37996828 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)