Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients (FRAILSMV)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fatıma Beyza Artıran, MD
- Phone Number: 05073622219
- Email: beyzaartiran@gmail.com
Study Locations
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Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Elective Cardiac Surgery Patients
Patients 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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:
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. |
Preoperative frailty assessment and the first 20 breaths of mask ventilation following induction of general anesthesia, before endotracheal intubation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incremental Predictive Value of Handgrip Strength Beyond Preoperative Frailty for Suboptimal Mask Ventilation
Time Frame: Preoperative CFS and handgrip strength assessment and the first 20 breaths of mask ventilation following induction of general anesthesia.
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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 |
Preoperative CFS and handgrip strength assessment and the first 20 breaths of mask ventilation following induction of general anesthesia.
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Association Between Suboptimal Mask Ventilation and Tracheal Intubation Difficulty
Time Frame: During the first 20 breaths of mask ventilation and subsequent tracheal intubation following induction of general anesthesia.
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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:
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. |
During the first 20 breaths of mask ventilation and subsequent tracheal intubation following induction of general anesthesia.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeliha Aslı Demir, MD, Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FRAILSMV-2026-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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