An observational study in Frailty and Suboptimal Mask Ventilation, sponsored by Ankara City Hospital Bilkent. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Ankara City Hospital Bilkent · Observational
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.
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 450 is above the median of 225 across 493 observational studies indexed under Frailty.
Browse Frailty studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Mask Ventilation During Routine Anesthesia Induction
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.
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.
Time frame: Preoperative frailty assessment and the first 20 breaths of mask ventilation following induction of general anesthesia, before endotracheal intubation.
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
Time frame: Preoperative CFS and handgrip strength assessment and the first 20 breaths of mask ventilation following induction of general anesthesia.
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.
Time frame: During the first 20 breaths of mask ventilation and subsequent tracheal intubation following induction of general anesthesia.
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ankara City Hospital Bilkent →