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

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

1. Success Rate of Ventilation:

Definition: The primary measure of success will be defined as achieving effective ventilation within a set timeframe. Effective ventilation is indicated by:
1. Visible and adequate chest rise and fall.
2. chest expansion by ultra-sounded guided diaphragmatic excursion at certain time 30, 60, 90, 120 second.
3. End tidal Co2 in Capnography at certain time 30, 60, 90, 120 second.
4. Oxygen saturation (SpO2) levels reaching ≥ 95% within 2 minutes of applying the ventilation technique.
5. Exhaled Tidal Volume at certain time 30, 60, 90, 120 second.
6. Peak Inspiratory Pressure (PIP).

Measurement:

• 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
1. Time to Achieve Effective Ventilation:

Definition: The time taken from the initiation of the ventilation technique to the point at which effective ventilation is confirmed.

Measurement:

• 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.
2. Rate of Ventilation Attempts:

Definition: The number of attempts needed to achieve effective ventilation.

Measurement:

Each attempt is defined as a discrete application of the ventilation technique. Multiple attempts within the 2-minute timeframe will be recorded and analyzed. The number of attempts required to achieve successful ventilation will be compared across the three techniques to assess reliability and ease of achieving effective ventilation.
3. Incidence of Ventilation Failure:

Definition: Failure to achieve effective ventilation within the 2-minute timeframe.

Measurement:

Any cases where effective ventilation is not achieved within 2 minutes will be documented.

The reasons for failure (e.g., difficulty in mask seal, inadequate chest rise) will be recorded and analyzed to understand the limitations of each technique.
4. Complications:

Document any airway trauma, hypoxem

Conditions

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

Interventions

PROCEDURE

E-C Clamp Technique

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.

PROCEDURE

T-E Technique

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.

PROCEDURE

The Hook Technique

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.

Sponsors & Collaborators

• Aswan University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2026-03-27

Completion

2026-03-27

Countries

• Egypt

Study Locations