Cleft PalateNCT07651904
Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring
An observational study of Cleft Palate and Cleft Lip, run by Marmara University Pendik Training and Research Hospital.
Trial summary
Cleft lip and palate surgeries present unique anesthetic challenges due to shared airway access with the surgical field, frequent anatomical abnormalities, and a predominantly infant and toddler population. Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Cleft Palate, Cleft Lip, Laryngospasm
- What is being tested?
- Standard General Anesthesia per Institutional Protocol
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2026to 30 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 0 to 3 years
- All sexes
- Child
Study population: Infants and toddlers aged 0-3 years scheduled for elective cleft lip and/or palate repair under general anesthesia . No randomization is performed; all management follows routine institutional anesthesia practice.
Who may be able to join
- Age 0-3 years (infants and toddlers)
- Scheduled for elective cleft lip and/or palate repair surgery
- General anesthesia planned
- Written parental/guardian informed consent obtained
Who cannot join
- Pre-existing respiratory failure or active tracheostomy
- Emergency surgical procedures
- Inability to obtain parental/guardian consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Assessment of Perioperative Respiratory Adverse Events in Pediatric Patients Undergoing Cleft Lip and Palate Surgery: Predictive Risk Factors and the Role of Clinical Airway Scores
Cleft lip and palate surgeries present unique anesthetic challenges due to shared airway access with the surgical field, frequent anatomical abnormalities, and a predominantly infant and toddler population. These factors substantially increase the risk of perioperative respiratory adverse events (PRAEs), including laryngospasm, bronchospasm, desaturation, post-extubation stridor, and unanticipated re-intubation.
This prospective single-center observational cohort study aims to determine the true incidence of PRAEs in pediatric patients undergoing elective cleft lip and/or palate repair under general anesthesia, and to identify independent predictive risk factors using standardized airway assessment tools including the Han Mask Ventilation Score and the Intubation Difficulty Score (IDS). No interventions beyond routine clinical practice will be applied. All airway management decisions will remain at the discretion of the attending anesthesiologist.
Read the detailed description
Cleft lip and palate are among the most common congenital craniofacial anomalies.
The surgical population predominantly consists of infants and young children who may present with associated syndromes, micrognathia, retrognathia, or obstructive sleep apnea - all of which contribute to difficult mask ventilation and difficult intubation. Sharing the airway with the surgical team and the use of the Dingman retractor further increase the risk of airway compromise during emergence and extubation. Published data on PRAE incidence in this population are largely retrospective and heterogeneous, and no adequately powered prospective study has systematically evaluated predictive risk factors using validated scoring systems.
Study Design:
Prospective, single-center, observational cohort study conducted at Marmara University Pendik Training and Research Hospital, Istanbul, Turkey. No interventions beyond established routine anesthesia protocols will be performed. Parental written informed consent will be obtained prior to enrollment.
Anesthetic Protocol:
All patients will undergo standard intraoperative monitoring (ECG, non-invasive blood pressure, pulse oximetry, end-tidal CO₂). Anesthesia will be induced with sevoflurane inhalation followed by intravenous induction after vascular access. Maintenance will be achieved with sevoflurane and remifentanil infusion. Analgesia and perioperative steroid administration will follow the department's routine protocol.
Data Collection:
Preoperative variables: age, weight, cleft type (unilateral/bilateral/isolated lip/isolated palate/combined), cleft width and depth, alveolar gap, micrognathia, retrognathia, cervical extension limitation, OSAS history, Pierre Robin sequence, and prior ICU admission.
Intraoperative variables: induction type and agents, neuromuscular blockade use, operator experience level, mask ventilation difficulty (Han Score), number of intubation attempts, laryngoscopy device used, Cormack-Lehane grade, VIDIAC score, IDS score, adjunct airway tools employed, minimum SpO₂ and bradycardia during intubation, Dingman retractor duration, and steroid use.
Primary outcome assessment: extubation-related minimum SpO₂, laryngospasm, bronchospasm, post-extubation stridor, coughing episodes, and need for unplanned re-intubation or ICU admission.
Vital signs (heart rate, SpO₂, blood pressure) will be recorded at intubation, 15, 30, 60, 90, 120 minutes intraoperatively, and postoperatively.
Statistical Analysis:
Descriptive statistics will be reported as mean ± SD or median (IQR) for continuous variables and as n (%) for categorical variables. Univariate comparisons between PRAE and non-PRAE groups will employ independent samples t-test, Mann-Whitney U test, chi-square, or Fisher's exact test as appropriate. Independent predictors of PRAE will be identified via binary logistic regression (backward stepwise method), reported as odds ratios (OR) with 95% confidence intervals. Statistical significance threshold: p<0.05.
Sample Size:
Based on a reported PRAE incidence of ~25% in comparable populations, a minimum of 120 patients is required (α=0.05, power=80%, G*Power 3.1). Accounting for anticipated dropout and exclusions, the target enrollment is 140-150 patients.
- Conditions
- Cleft Palate, Cleft Lip, Laryngospasm, Bronchospasm, Airway Obstruction, Postoperative Complications
- Being tested
- Standard General Anesthesia per Institutional Protocol
- Keywords
- cleft lip, cleft palate, pediatric anesthesia, perioperative respiratory adverse events, Han mask ventilation score, micrognathia, intubation difficulty score
- Medical subject headings
- Cleft Palate, Cleft Lip, Laryngismus, Bronchial Spasm, Airway Obstruction, Postoperative Complications, Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard General Anesthesia per Institutional ProtocolOther
No interventions beyond routine clinical anesthesia practice. All airway management decisions, including induction technique, laryngoscopy device selection, and extubation strategy, are made at the discretion of the attending anesthesiologist. Observational data collection only.
| Study group | Role | What they receive |
|---|---|---|
| Cleft Lip and/or Palate Surgery Cohort | Pediatric patients aged 0-3 years undergoing elective cleft lip and/or palate repair under general anesthesia. All subjects are managed per routine anesthesia protocol. Perioperative airway events and predictive clinical variables are prospectively recorded from induction through PACU discharge. Receives: Other: Standard General Anesthesia per Institutional Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Perioperative Respiratory Adverse Events (PRAEs)
Composite outcome defined as the occurrence of at least one of the following: laryngospasm, bronchospasm, post-extubation stridor, oxygen desaturation lasting >10 seconds (SpO₂ <90%), or unplanned re-intubation, occurring at any point from induction through PACU discharge
Measured: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
Secondary outcomes (7)
Independent Predictors of PRAE - Odds Ratios
Identification of independent risk factors for PRAE via binary logistic regression, including Han Mask Ventilation Score, IDS, age, cleft type, micrognathia, retrognathia, OSAS, Pierre Robin sequence, and passive smoke exposure. Results reported as OR (95% CI).
Measured: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
Intubation Difficulty Score (IDS)
Composite intubation difficulty score (Adnet 1997) calculated as N1-N7 sum; IDS ≥5 defined as difficult intubation.
Measured: Intraoperative
Han Mask Ventilation Score
Four-point scale assessing difficulty of mask ventilation; score ≥2 considered indicative of elevated PRAE risk.
Measured: Intraoperative, at time of mask ventilation
Minimum SpO₂ During Intubation
Intraoperative
Measured: Lowest pulse oximetry value recorded during laryngoscopy and intubation attempts.
Minimum SpO₂ During Extubation
At extubation
Measured: Lowest pulse oximetry value recorded during and immediately after extubation.
Postoperative ICU Admission Rate
Proportion of patients requiring unplanned postoperative intensive care unit admission.
Measured: Within 24 hours of surgery
Postoperative Hospital Length of Stay
Total duration of hospital stay in days.
Measured: From surgery to hospital discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start27 Jun 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilara gocmen, Marmara University Pendik Training and Research Hospital
- Investigators
- dilara göçmen, Principal investigator, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651904
- Sponsor's protocol ID
- mar anest
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Feyrer J, Irouschek A, Golditz T, Schmidt J, Lutz R, Kesting M, Moritz A. Airway Management in Children Undergoing Cleft Lip or Cleft Palate Surgery: An 8-Year Retrospective Analysis of 274 Cases. Paediatr Anaesth. 2025 Nov;35(11):925-933. doi: 10.1111/pan.70038. Epub 2025 Aug 16.
PubMed 40817740Han R, Tremper KK, Kheterpal S, O'Reilly M. Grading scale for mask ventilation. Anesthesiology. 2004 Jul;101(1):267. doi: 10.1097/00000542-200407000-00059. No abstract available.
PubMed 15220820Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
PubMed 9416711Somerville N, Fenlon S. Anaesthesia For Cleft Lip And Palate Surgery. Continuing Education İn Anaesthesia, Critical Care And Pain. 2005/06/01;5(3).
Tümer M, Ankay Yılbaş A, Soysal Kaya M, Karakoyak B, Kaya K, Canbay Ö, Et Al. Anesthetic Approach And Perioperative Complications İn Cleft Lip / Palate Surgery: A Single Center Retrospective Study. ERCIYES MEDICAL JOURNAL. 2022;44
Gupta N, Nagar K, Dixit P, Tiwari T, Srivastava VK, Singh PR. Airway Consideration İn Cleft Patients-Challenges And Approaches. Journal Of Cleft Lip Palate And Craniofacial Anomalies. Jan-Jun 2022;9(1).
Denning S, Ng E, Wong Riff KWY. Anaesthesia for cleft lip and palate surgery. BJA Educ. 2021 Oct;21(10):384-389. doi: 10.1016/j.bjae.2021.06.002. Epub 2021 Aug 25. No abstract available.
PubMed 34567793
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Perioperative Respiratory Adverse Events in Pediatric Patients Undergoing Cleft Lip and Palate Surgery: Predictive Risk Factors and the Role of Clinical Airway Scores
- ClinicalTrials.gov ID
- NCT07651904
- Acronym / sponsor ID
- mar anest
- Conditions
- Cleft Palate, Cleft Lip, Laryngospasm, Bronchospasm, Airway Obstruction, Postoperative Complications
- Keywords
- cleft lip, cleft palate, pediatric anesthesia, perioperative respiratory adverse events, Han mask ventilation score, micrognathia, intubation difficulty score
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 27 Jun 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cleft lip and palate surgeries present unique anesthetic challenges due to shared airway access with the surgical field, frequent anatomical abnormalities, and a predominantly infant and toddler population. These factors substantially increase the risk of perioperative respiratory adverse events (PRAEs), including laryngospasm, bronchospasm, desaturation, post-extubation stridor, and unanticipated re-intubation.
This prospective single-center observational cohort study aims to determine the true incidence of PRAEs in pediatric patients undergoing elective cleft lip and/or palate repair under general anesthesia, and to identify independent predictive risk factors using standardized airway assessment tools including the Han Mask Ventilation Score and the Intubation Difficulty Score (IDS). No interventions beyond routine clinical practice will be applied. All airway management decisions will remain at the discretion of the attending anesthesiologist.
Detailed description
Cleft lip and palate are among the most common congenital craniofacial anomalies.
The surgical population predominantly consists of infants and young children who may present with associated syndromes, micrognathia, retrognathia, or obstructive sleep apnea - all of which contribute to difficult mask ventilation and difficult intubation. Sharing the airway with the surgical team and the use of the Dingman retractor further increase the risk of airway compromise during emergence and extubation. Published data on PRAE incidence in this population are largely retrospective and heterogeneous, and no adequately powered prospective study has systematically evaluated predictive risk factors using validated scoring systems.
Study Design:
Prospective, single-center, observational cohort study conducted at Marmara University Pendik Training and Research Hospital, Istanbul, Turkey. No interventions beyond established routine anesthesia protocols will be performed. Parental written informed consent will be obtained prior to enrollment.
Anesthetic Protocol:
All patients will undergo standard intraoperative monitoring (ECG, non-invasive blood pressure, pulse oximetry, end-tidal CO₂). Anesthesia will be induced with sevoflurane inhalation followed by intravenous induction after vascular access. Maintenance will be achieved with sevoflurane and remifentanil infusion. Analgesia and perioperative steroid administration will follow the department's routine protocol.
Data Collection:
Preoperative variables: age, weight, cleft type (unilateral/bilateral/isolated lip/isolated palate/combined), cleft width and depth, alveolar gap, micrognathia, retrognathia, cervical extension limitation, OSAS history, Pierre Robin sequence, and prior ICU admission.
Intraoperative variables: induction type and agents, neuromuscular blockade use, operator experience level, mask ventilation difficulty (Han Score), number of intubation attempts, laryngoscopy device used, Cormack-Lehane grade, VIDIAC score, IDS score, adjunct airway tools employed, minimum SpO₂ and bradycardia during intubation, Dingman retractor duration, and steroid use.
Primary outcome assessment: extubation-related minimum SpO₂, laryngospasm, bronchospasm, post-extubation stridor, coughing episodes, and need for unplanned re-intubation or ICU admission.
Vital signs (heart rate, SpO₂, blood pressure) will be recorded at intubation, 15, 30, 60, 90, 120 minutes intraoperatively, and postoperatively.
Statistical Analysis:
Descriptive statistics will be reported as mean ± SD or median (IQR) for continuous variables and as n (%) for categorical variables. Univariate comparisons between PRAE and non-PRAE groups will employ independent samples t-test, Mann-Whitney U test, chi-square, or Fisher's exact test as appropriate. Independent predictors of PRAE will be identified via binary logistic regression (backward stepwise method), reported as odds ratios (OR) with 95% confidence intervals. Statistical significance threshold: p<0.05.
Sample Size:
Based on a reported PRAE incidence of ~25% in comparable populations, a minimum of 120 patients is required (α=0.05, power=80%, G*Power 3.1). Accounting for anticipated dropout and exclusions, the target enrollment is 140-150 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cleft Lip and/or Palate Surgery Cohort | – | Other: Standard General Anesthesia per Institutional ProtocolPediatric patients aged 0-3 years undergoing elective cleft lip and/or palate repair under general anesthesia. All subjects are managed per routine anesthesia protocol. Perioperative airway events and predictive clinical variables are prospectively recorded from induction through PACU discharge. |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- Infants and toddlers aged 0-3 years scheduled for elective cleft lip and/or palate repair under general anesthesia . No randomization is performed; all management follows routine institutional anesthesia practice.
Key inclusion criteria (4 listed)
- Age 0-3 years (infants and toddlers)
- Scheduled for elective cleft lip and/or palate repair surgery
- General anesthesia planned
- Written parental/guardian informed consent obtained
Key exclusion criteria (3 listed)
- Pre-existing respiratory failure or active tracheostomy
- Emergency surgical procedures
- Inability to obtain parental/guardian consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard General Anesthesia per Institutional ProtocolNo interventions beyond routine clinical anesthesia practice. All airway management decisions, including induction technique, laryngoscopy device selection, and extubation strategy, are made at the discretion of the attending anesthesiologist. Observational data collection only. | Other | Cleft Lip and/or Palate Surgery Cohort |
Primary outcome
Incidence of Perioperative Respiratory Adverse Events (PRAEs)
Time frame: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
Composite outcome defined as the occurrence of at least one of the following: laryngospasm, bronchospasm, post-extubation stridor, oxygen desaturation lasting >10 seconds (SpO₂ <90%), or unplanned re-intubation, occurring at any point from induction through PACU discharge
7 secondary outcomes
Independent Predictors of PRAE - Odds Ratios
Time frame: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
Intubation Difficulty Score (IDS)
Time frame: Intraoperative
Han Mask Ventilation Score
Time frame: Intraoperative, at time of mask ventilation
Minimum SpO₂ During Intubation
Time frame: Lowest pulse oximetry value recorded during laryngoscopy and intubation attempts.
Minimum SpO₂ During Extubation
Time frame: Lowest pulse oximetry value recorded during and immediately after extubation.
Postoperative ICU Admission Rate
Time frame: Within 24 hours of surgery
Postoperative Hospital Length of Stay
Time frame: From surgery to hospital discharge, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 40817740Feyrer J, Irouschek A, Golditz T, Schmidt J, Lutz R, Kesting M, Moritz A. Airway Management in Children Undergoing Cleft Lip or Cleft Palate Surgery: An 8-Year Retrospective Analysis of 274 Cases. Paediatr Anaesth. 2025 Nov;35(11):925-933. doi: 10.1111/pan.70038. Epub 2025 Aug 16.
- Background: PubMed 15220820Han R, Tremper KK, Kheterpal S, O'Reilly M. Grading scale for mask ventilation. Anesthesiology. 2004 Jul;101(1):267. doi: 10.1097/00000542-200407000-00059. No abstract available.
- Background: PubMed 9416711Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
- BackgroundSomerville N, Fenlon S. Anaesthesia For Cleft Lip And Palate Surgery. Continuing Education İn Anaesthesia, Critical Care And Pain. 2005/06/01;5(3).
- BackgroundTümer M, Ankay Yılbaş A, Soysal Kaya M, Karakoyak B, Kaya K, Canbay Ö, Et Al. Anesthetic Approach And Perioperative Complications İn Cleft Lip / Palate Surgery: A Single Center Retrospective Study. ERCIYES MEDICAL JOURNAL. 2022;44
- BackgroundGupta N, Nagar K, Dixit P, Tiwari T, Srivastava VK, Singh PR. Airway Consideration İn Cleft Patients-Challenges And Approaches. Journal Of Cleft Lip Palate And Craniofacial Anomalies. Jan-Jun 2022;9(1).
- Background: PubMed 34567793Denning S, Ng E, Wong Riff KWY. Anaesthesia for cleft lip and palate surgery. BJA Educ. 2021 Oct;21(10):384-389. doi: 10.1016/j.bjae.2021.06.002. Epub 2021 Aug 25. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
dilara göçmen principal investigator
Marmara University Pendik Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate and Cleft Lip, run by Marmara University Pendik Training and Research Hospital.
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 4 inclusion and 3 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Dilara Göçmen (+90 216 625 45 45, dilara.gocmen@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Perioperative Respiratory Adverse Events (PRAEs) (time frame: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.). 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 NCT07651904, which also lists 7 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 16 Jun 2026.