Effectiveness of Facial Mask NIV in Adults Under General Anesthesia: Two-Hand C-E vs V-E Techniques

NCT07179432 | Recruiting

• 1 other identifier: IN31-2024
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to compare two different ways doctors hold a face mask to help the participant breathe during general anesthesia. The investigators are evaluating which method, the "C-E" or the "V-E" technique, works best. If the participant chooses to take part, on the day of surgery, after anesthesia has been administered and the participant is asleep, the doctor will use one of these two mask-holding techniques to assist breathing for a short period. The investigators will measure how effectively the participant is breathing, check carbon dioxide levels, and record the doctors' assessment of how easy and comfortable each technique was for them. This study will not alter any other aspect of the surgery or recovery.

Conditions

General Anesthetics

Keywords

ventilation; mask ventilation

Outcome Measures

Primary Outcomes (1)

• Ventilation ml/kg

  Average ventilation in milliliters per kilogram of body weight for seven ventilations recorded on the anesthesia machine at the end of expiration.

  10 minutes during procedure

Secondary Outcomes (4)

• Average CO2 mmHg

  10 minutes during procedure

• Ineffective ventilation

  10 minutes during procedure

• Operator satisfaction.

  10 minutes during procedure

• Hypoxemia

  10 minutes during procedure

Other Outcomes (1)

• Adverse events by group.

  Perioperative/Periprocedural

Study Arms (2)

Two-Hand V-E Maneuver Facial Mask Ventilation.

EXPERIMENTAL

The V-E maneuver is achieved by placing the thumbs and thenar eminence of each hand on the sides of the mask, creating a "V" shape, while the rest of the fingers perform a jaw thrust described as an "E" shape. This will be performed after anesthetic induction when the patient is unconscious and apneic.

Procedure: V-E facial mask ventilation maneuver

C-E facial mask ventilation maneuver

ACTIVE COMPARATOR

The C-E maneuver is achieved by placing the thumb and index finger of each hand on the mask in a "C" shape, while the third, fourth, and fifth fingers of both hands perform a jaw thrust towards the mask in an "E" shape. This will also be performed after anesthetic induction when the patient is unconscious and apneic.

Procedure: C-E facial mask ventilation maneuver

Interventions

V-E facial mask ventilation maneuver PROCEDURE

The V-E maneuver is achieved by placing the thumbs and thenar eminence of each hand on the sides of the mask, creating a "V" shape, while the rest of the fingers perform a jaw thrust described as an "E" shape. This will be performed after anesthetic induction when the patient is unconscious and apneic. The C-E maneuver is achieved by placing the thumb and index finger of each hand on the mask in a "C" shape, while the third, fourth, and fifth fingers of both hands perform a jaw thrust towards the mask in an "E" shape. This will also be performed after anesthetic induction when the patient is unconscious and apneic.

Two-Hand V-E Maneuver Facial Mask Ventilation.

C-E facial mask ventilation maneuver PROCEDURE

The C-E maneuver is achieved by placing the thumb and index finger of each hand on the mask in a "C" shape, while the third, fourth, and fifth fingers of both hands perform a jaw thrust towards the mask in an "E" shape. This will also be performed after anesthetic induction when the patient is unconscious and apneic.

C-E facial mask ventilation maneuver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years old
• Scheduled for elective surgery
• Require general anesthesia
• Consent to participate in the study

You may not qualify if:

• Presence of predictors of difficult ventilation: presence of a beard, --obstructive sleep apnea/hypopnea syndrome
• Anticipated difficult airway
• Classified as ASA IV or higher
• Oxygen saturation less than 92% upon admission
• Requirement for supplemental oxygen

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (2)

Hospital alma Mater de Antioquia

Medellín, Antioquia, 050021, Colombia

RECRUITING

Antioquia´s University

Medellín, Colombia

RECRUITING

Related Publications (4)

• Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.

  PMID: 21447489 BACKGROUND

• Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Kovacs G, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Jones PM; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 2. Planning and implementing safe management of the patient with an anticipated difficult airway. Can J Anaesth. 2021 Sep;68(9):1405-1436. doi: 10.1007/s12630-021-02008-z. Epub 2021 Jun 8.

  PMID: 34105065 BACKGROUND

• Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.

  PMID: 17065880 BACKGROUND

• Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.

  PMID: 34762729 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mario Zamudio, Anesthesiologist

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Zamudio, Anesthesiologist

CONTACT

+57 3003456596; mario.zamudio@udea.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Generation of the Random Allocation Sequence The sequence will be generated using the latest version of R software with permuted blocks of 2, 4, and 6 participants with variable block sizes, and one stratification variable: use of an oropharyngeal cannula. Allocation Concealment Mechanism The allocation will be kept in an opaque envelope that does not allow the assigned group to be seen. Implementation The envelope will be opened only by one of the investigators after completing the inclusion criteria and signing the informed consent Blinding Patient: Will be blinded as they will be under general anesthesia Outcome Evaluator Will be blinded as their analysis will be conducted on videos recorded by the research team
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University professor with a master's degree in clinical epidemiology

Model Details: Controlled clinical trial with two parallel groups, randomized 1:1, superiority design, blinded to the patient and data analyst.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 17, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: at least five years
• Access Criteria: contact to investigator

Locations

CO (2)