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FrailtyFRAILSMVNCT07916675

Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients

An observational study of Frailty and Suboptimal Mask Ventilation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to investigate whether frailty before surgery is associated with difficulty providing adequate breathing support through a face mask after the start of general anesthesia in patients aged 60 years and older undergoing elective cardiac surgery. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Frailty, Suboptimal Mask Ventilation
What is being tested?
Mask Ventilation During Routine Anesthesia Induction
How many people
450 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Nov 2026to Dec 2027
Phase
Observational
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will consist of patients aged 60 years and older with American Society of Anesthesiologists (ASA) physical status II-IV who are scheduled for elective coronary artery bypass grafting, valve surgery, or combined cardiovascular surgery under general anesthesia at Ankara Bilkent City Hospital. Eligible patients will be consecutively recruited during the study period. Written informed consent will be obtained before enrollment. This single-center, prospective observational study will not alter routine anesthesia or surgical care.

Who may be able to join

  • Patients aged 60 years or older
  • Patients scheduled for elective cardiac surgery, including:
  • Coronary artery bypass grafting (CABG)
  • Valve surgery
  • Combined cardiovascular surgery
  • Patients undergoing surgery under general anesthesia
Show all 10Show fewer
  • Patients who can undergo preoperative frailty assessment
  • Patients who can undergo handgrip strength measurement
  • Patients who provide written informed consent
  • American Society of Anesthesiologists (ASA) physical status II-IV

Who cannot join

  • Emergency cardiac surgery
  • Patients with a tracheostomy
  • Planned awake fiberoptic intubation
  • Requirement for rapid sequence induction
  • Facial deformities, restricted neck mobility, or a history of head and neck surgery and/or radiation therapy that may interfere with mask ventilation
  • Neuromuscular disorders that prevent handgrip strength measurement
  • Patients unable to cooperate with study assessments
  • Patients who decline to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fatıma Beyza Artıran, MD contact

05073622219

beyzaartiran@gmail.com

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Association Between Preoperative Frailty and Suboptimal Mask Ventilation in Adult Cardiac Surgery Patients: A Prospective Observational Study

This study aims to investigate whether frailty before surgery is associated with difficulty providing adequate breathing support through a face mask after the start of general anesthesia in patients aged 60 years and older undergoing elective cardiac surgery.

Frailty describes reduced physical reserves and an increased vulnerability to health-related stress. Before surgery, participants will be assessed using the Clinical Frailty Scale, and handgrip strength will be measured using a handheld dynamometer. These assessments will be evaluated alongside routine patient characteristics and airway measurements.

Read more

During routine anesthesia care, the research team will record how effectively patients can be ventilated through a face mask during the first 20 breaths after anesthesia induction. The team will also record the need for additional airway support and any difficulty placing the breathing tube.

The main objective is to assess the association between preoperative frailty and suboptimal mask ventilation. Additional objectives are to assess the association between handgrip strength and suboptimal mask ventilation, whether handgrip strength adds predictive information beyond frailty assessment, and the relationship between suboptimal mask ventilation and intubation difficulty.

This is a single-center, prospective observational study at Ankara Bilkent City Hospital. The study will not change participants' routine anesthesia or surgical care.

Read the detailed description

This single-center, prospective observational study will consecutively enroll eligible patients aged 60 years and older with American Society of Anesthesiologists (ASA) physical status II-IV who are scheduled for elective coronary artery bypass grafting, valve surgery, or combined cardiac surgery under general anesthesia at Ankara Bilkent City Hospital. Written informed consent will be obtained before participation. The study will not alter routine anesthesia or surgical care. Demographic and clinical characteristics, body mass index, comorbidities, left ventricular ejection fraction, and planned surgical procedure will be recorded. Airway assessment will include Mallampati class, thyromental distance, neck circumference, and the neck circumference-to-thyromental distance ratio. Preoperative frailty will be assessed using the 9-point Clinical Frailty Scale (CFS), ranging from 1 (Very Fit) to 9 (Terminally Ill). Higher scores generally indicate greater frailty; a score of 9 denotes terminal illness. Assessment will be based on clinical evaluation and patient interview. For the primary analysis, patients with CFS scores ≥4 will be classified as belonging to the vulnerable/frail spectrum, and patients with scores <4 will form the comparison category. Handgrip strength will be measured preoperatively using a calibrated hand dynamometer. Measurements will be obtained from the dominant hand with the patient seated, the shoulder adducted and in neutral rotation, and the elbow flexed at 90 degrees. Three measurements will be obtained, and their mean value, expressed in kilograms, will be used in the analyses. Low muscle strength will be defined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria as handgrip strength <27 kg in men and <16 kg in women. Handgrip strength will be evaluated both as a continuous variable and as a categorical variable according to these sex-specific thresholds. Its association with suboptimal mask ventilation and its additional predictive value beyond frailty assessment will be investigated. Following preoxygenation, intravenous anesthesia induction and neuromuscular blockade will be performed as part of routine clinical care. Patients will be positioned supine. Mask ventilation will initially be performed using a one-handed mask-holding technique, with the other hand used to manually compress the reservoir bag. Initial peak inspiratory pressure will be limited to 20 cmH₂O. Ventilation adequacy will be assessed during the first 20 breaths after anesthesia induction. Exhaled tidal volume, end-tidal carbon dioxide waveform, peak inspiratory pressure, and peripheral oxygen saturation will be recorded. If ventilation is inadequate, standard airway optimization measures will be undertaken, including oropharyngeal airway placement, adjustment of inspiratory pressure, and two-person ventilation, as clinically required. Use of an oropharyngeal or nasopharyngeal airway and the requirement for two-person ventilation will be documented. Mask ventilation will be performed by an anesthesia resident with at least four years of experience. Suboptimal mask ventilation (SMV) will be defined as the presence of at least one of the following criteria during assessment of the first 20 breaths: exhaled tidal volume <5 mL/kg of ideal body weight; an absent or inadequate end-tidal carbon dioxide waveform; requirement for two-person mask ventilation; requirement for an oropharyngeal or nasopharyngeal airway; or peripheral oxygen saturation <92%. SMV will be recorded as a binary outcome, indicating whether one or more of these criteria are present. During subsequent tracheal intubation, the laryngoscopic view will be graded using the Cormack-Lehane classification. The number of intubation attempts and first-attempt intubation success will also be recorded. Preoperative frailty and handgrip strength assessments and intraoperative mask ventilation assessments will be performed by different investigators. The investigator assessing intraoperative mask ventilation will be blinded to the preoperative CFS and handgrip strength results. The primary outcome is the occurrence of SMV. The primary objective is to evaluate the association between preoperative frailty and SMV. Secondary outcomes include the lowest peripheral oxygen saturation, ventilation parameters, airway adjunct use, requirement for two-person ventilation, Cormack-Lehane grade, number of intubation attempts, and first-attempt intubation success. Secondary objectives are to evaluate the association between handgrip strength and SMV, determine whether handgrip strength provides additional predictive information beyond frailty assessment, and investigate the relationship between SMV and intubation difficulty. Multivariable logistic regression and receiver operating characteristic curve analyses are planned. A total of 450 participants will be enrolled, allowing for approximately 10% data loss. Recruitment and prospective data collection are expected to take approximately one year.

Being tested
Mask Ventilation During Routine Anesthesia Induction
Keywords
Cardiac Surgery, Handgrip Strength, Clinical Frailty Scale, Difficult Mask Ventilation, Airway Management, General Anesthesia
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mask Ventilation During Routine Anesthesia InductionProcedure or surgery

    Mask ventilation will be performed during routine anesthesia induction following preoxygenation, intravenous induction, and neuromuscular blockade. With the patient supine, ventilation will initially be performed using a one-handed mask-holding technique and manual reservoir bag compression, with initial peak inspiratory pressure limited to 20 cmH₂O. Ventilation adequacy will be assessed during the first 20 breaths by recording exhaled tidal volume, end-tidal carbon dioxide waveform, peak inspiratory pressure, and peripheral oxygen saturation. Airway adjunct use and the requirement for two-person ventilation will be documented. Standard airway optimization measures will be applied promptly as clinically required. Mask ventilation will be performed by an anesthesia resident with at least four years of experience who is blinded to preoperative frailty and handgrip strength results. This procedure is part of routine clinical care.

Study groups in NCT07916675
Study groupRoleWhat they receive
Elective Cardiac Surgery PatientsPatients aged 60 years and older with ASA physical status II-IV undergoing elective coronary artery bypass grafting, valve surgery, or combined cardiac surgery under general anesthesia. Participants will undergo preoperative Clinical Frailty Scale assessment and handgrip strength measurement. Mask ventilation adequacy will be assessed during the first 20 breaths after anesthesia induction, and intubation characteristics will be recorded during routine clinical care.
Receives: Procedure: Mask Ventilation During Routine Anesthesia Induction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association Between Preoperative Frailty and Suboptimal Mask Ventilation in Patients Aged 60 Years and Older Undergoing Elective Cardiac Surgery

    Preoperative frailty will be assessed using the 9-point Clinical Frailty Scale (CFS; scores 1-9). Patients with CFS ≥4 will be classified as vulnerable/frail and those with CFS <4 as the comparison group.

    Suboptimal mask ventilation (SMV) will be assessed during the first 20 breaths of face-mask ventilation after induction of general anesthesia and before endotracheal intubation. SMV will be defined by ≥1 of the following:

    1. Exhaled tidal volume <5 mL/kg ideal body weight.
    2. Absent or inadequate end-tidal CO2 waveform.
    3. Need for two-person mask ventilation.
    4. Need for an oropharyngeal or nasopharyngeal airway.
    5. SpO2 <92%.

    SMV will be recorded as a binary outcome (yes/no). SMV occurrence will be compared between CFS groups, and its association with frailty will be assessed using multivariable logistic regression.

    Measured: Preoperative frailty assessment and the first 20 breaths of mask ventilation following induction of general anesthesia, before endotracheal intubation.

Secondary outcomes (2)
  1. Incremental Predictive Value of Handgrip Strength Beyond Preoperative Frailty for Suboptimal Mask Ventilation

    The incremental predictive value of preoperative handgrip strength beyond frailty assessment using the Clinical Frailty Scale (CFS) will be investigated for the occurrence of suboptimal mask ventilation (SMV) following induction of general anesthesia.

    Preoperative frailty will be assessed using the 9-point CFS. Patients with CFS scores ≥4 will be classified as belonging to the vulnerable/frail spectrum, while patients with CFS scores <4 will form the comparison group.

    Handgrip strength will be assessed using the mean of three measurements obtained from the dominant hand with a calibrated hand dynamometer.

    Multivariable logistic regression models will be used to evaluate whether the addition of handgrip strength to frailty assessment improves the prediction of SMV.

    Receiver operating characteristic (ROC) curve analyses will be performed to compare model discrimination. The area under the ROC curve (AUC) will be used to evaluate the additional predictive value of handgrip strength b

    Measured: Preoperative CFS and handgrip strength assessment and the first 20 breaths of mask ventilation following induction of general anesthesia.

  2. Association Between Suboptimal Mask Ventilation and Tracheal Intubation Difficulty

    The association between suboptimal mask ventilation (SMV) and subsequent tracheal intubation difficulty will be investigated in patients aged 60 years and older undergoing elective cardiac surgery.

    SMV will be assessed during the first 20 breaths following induction of general anesthesia according to the predefined criteria.

    During subsequent tracheal intubation, the following parameters will be recorded:

    1. Laryngoscopic view according to the Cormack-Lehane classification (Grades I-IV).
    2. Number of tracheal intubation attempts.
    3. First-attempt intubation success (yes/no).

    The distribution of Cormack-Lehane grades, number of intubation attempts, and first-attempt intubation success will be compared between patients with and without SMV.

    The relationship between SMV and these indicators of tracheal intubation difficulty will be evaluated using appropriate statistical analyses.

    Measured: During the first 20 breaths of mask ventilation and subsequent tracheal intubation following induction of general anesthesia.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start3 Nov 2026 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07916675
Sponsor's protocol ID
FRAILSMV-2026-003
Acronym
FRAILSMV
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a single-center academic observational study. Individual participant data (IPD) will not be shared publicly. Only de-identified aggregate study results will be reported in scientific publications.

Publications

  • Tasdemir O, Kocaoglu N, Demir HF, Ugun F, Sagir O. Ultrasound-based airway assessment in obese patients as a valuable tool for predicting difficult airway: an observational study. Braz J Anesthesiol. 2024 Nov-Dec;74(6):844539. doi: 10.1016/j.bjane.2024.844539. Epub 2024 Jul 10.

    PubMed 38997064
  • Markham T, AlFarra AS, Tejani M, Tate DJ, Barrera JE, Paladugu S, Saroukhani S, Jiang Y. Effectiveness of Ventilation via an Endotracheal Tube in Pharynx Versus a Facemask in Patients With Potentially Difficult Airway: A Randomized, Crossover, and Blind Trial. Anesth Analg. 2025 Feb 1;140(2):280-289. doi: 10.1213/ANE.0000000000007273. Epub 2024 Dec 20.

    PubMed 39705182
  • Hung KC, Chuang MH, Kang FC, Chang YJ, Lin CM, Yu CH, Chen IW, Sun CK. Prevalence and risk factors of difficult mask ventilation: A systematic review and meta-analysis. J Clin Anesth. 2023 Nov;90:111197. doi: 10.1016/j.jclinane.2023.111197. Epub 2023 Jul 4.

    PubMed 37413763
  • Bianchini A, Nardozi L, Nardi E, Scuppa MF. Airways ultrasound in predicting difficult face mask ventilation. Minerva Anestesiol. 2021 Jan;87(1):26-34. doi: 10.23736/S0375-9393.20.14455-9. Epub 2020 Oct 14.

    PubMed 33054014

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Suboptimal Mask Ventilation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

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 10 inclusion and 8 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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 Fatıma Beyza Artıran, MD (05073622219, beyzaartiran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association Between Preoperative Frailty and Suboptimal Mask Ventilation in Patients Aged 60 Years and Older Undergoing Elective Cardiac Surgery (time frame: Preoperative frailty assessment and the first 20 breaths of mask ventilation following induction of general anesthesia, before endotracheal intubation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07916675, which also lists 4 linked publications.

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 4 Nov 2026.

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