LaryngomalaciaNCT06627660
Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty
A study testing Valsalva maneuver in people with Laryngomalacia and Laryngospasm, run by Sameh Fathy.
Trial summary
We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia. Primary outcome: Incidence of postoperative stridor and laryngospasm Secondary outcome: incidence of reintubation, postoperative hemodynamics, duration of… Read more about this study
- Who is it for?
- Ages 1 month to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngomalacia, Laryngospasm
- What is being tested?
- Valsalva maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants and children ASA I or II aging from 1 month age - 6 years undergoing supraglottoplasty
Who cannot join
- Parents refusal.
- Patients with increased ICP
- Patients with increased IOP
Trial locations and contacts
No sites are listed yet.
About this study
We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.
Primary outcome: Incidence of postoperative stridor and laryngospasm Secondary outcome: incidence of reintubation, postoperative hemodynamics, duration of postoperative ICU and hospital stay
Read the detailed description
Congenital Laryngomalacia is the main cause of stridor in newborns and infants, affecting 45-75% of all infants with congenital stridor. Short aryepiglottic folds, redundant arytenoid, omega-shaped epiglottis, and inspiratory stridor are features of laryngomalacia. Pediatric laryngospasm is a glottic closure due to reflex constriction of the laryngeal muscles that produce partial or complete obstruction of the larynx. When complete and sustained, laryngospasm is considered an anesthetic Emergency.
The valsalva maneuver involves expiratory effort against a closed glottis in the sitting or supine position with the intraoral and intrathoracic pressures raised to 40 mmHg for 15-20 sec, after which the pressure is suddenly released and the breathing restored to normal.
We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.
After approval of IRB, Mansoura University, this study will be conducted on infants and children ASA I or II aging from 1 month age- 6 years undergoing supraglottoplasty in Mansoura university hospitals. After obtaining a written informed consent from patients parents, random number generator with closed envelope technique will randomize patients into two groups [control] group ( C group ), Valsalva group ( V group)].
Anesthesia will be induced by inhalational induction using sevoflurane at concentration (6:8%). After that, a proper sized cannula will be introduced with giving atropine 0,01mg/kg and hydrocortisone 4mg/ kg. Then, patients will be seen by fiberoptic endoscopy by the surgeon to detect the stage of laryngomalacia and the supraglottic pathology. After that, proper sized ETT will be inserted using succinylcholine 1mg\kg IV and fixed in place after confirmation of correct positioning , with maintenance of anesthesia with isoflurane. All patients will be given 0.5-1mic /kg fentanyl and 15 mg /kg paracetamol.
A pilot study will be done including 5 patients in each study group. The Incidence of postoperative stridor will be used as the primary variable with difference between studied groups was 40% (50% in group C versus 10% in group V). G*power software version 3.1.9.2 will be utilized to detect the required sample size for a study power of 90% and alpha error of 0.05. Cases involved in the pilot study will not be included in the total sample size of the study. Then total sample size will be 26 in each group and by adding 10% to compensate for possible drop out then total sample size per group will be 29 cases in each group. Perioperative data will be tabulated and analyzed using IBM SPSS software version 26.
- Conditions
- Laryngomalacia, Laryngospasm
- Being tested
- Valsalva maneuver
- Keywords
- VALSALVA MANEUVER, Postoperative Laryngospasm, Supraglottoplasty
- Medical subject headings
- Laryngomalacia, Laryngismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsalva maneuverProcedure or surgery
Closure of the nose and mouth during expiration for 20 sec
| Study group | Role | What they receive |
|---|---|---|
| Group C | No intervention | Control group |
| Group V | Active comparator | Repeated Valsalva maneuver will be done after recovery from anesthesia Receives: Procedure: Valsalva maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of laryngospasm
Measured: 24 HOURS
Secondary outcomes (4)
incidence of reintubation
Measured: 24 HOURS
Postoperative oxygen saturation measurement
Oxygen saturation (%) is recorded every 5 minutes
Measured: 1 HOUR
Incidence of postoperative nausea and vomiting
Measured: 24 HOURS
Duration of postoperative hospital stay
Measured: 24 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start6 Oct 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LaryngomalaciaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- INTERVENTIONAL
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sameh Fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Fathy, Mansoura University
- Investigators
- Ahmed Elshahat Aboelfoutouh, DOCTORAL DEGREE (MD), Principal investigator, Lecturer of Anesthesia and Surgical Intensive Care - Faculty of medicine - Mansoura universityRania Elmohamady Elbadrawy, DOCTORAL DEGREE (MD), Principal investigator, Lecturer of Anesthesia and Surgical Intensive Care- Faculty of medicine - Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627660
- Sponsor's protocol ID
- Valsalva for laryngospasm
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kumar CM, Van Zundert AAJ. Intraoperative Valsalva maneuver: a narrative review. Can J Anaesth. 2018 May;65(5):578-585. doi: 10.1007/s12630-018-1074-6. Epub 2018 Jan 24.
PubMed 29368315Ramprasad VH, Ryan MA, Farjat AE, Eapen RJ, Raynor EM. Practice patterns in supraglottoplasty and perioperative care. Int J Pediatr Otorhinolaryngol. 2016 Jul;86:118-23. doi: 10.1016/j.ijporl.2016.04.039. Epub 2016 May 3.
PubMed 27260594Alalami AA, Ayoub CM, Baraka AS. Laryngospasm: review of different prevention and treatment modalities. Paediatr Anaesth. 2008 Apr;18(4):281-8. doi: 10.1111/j.1460-9592.2008.02448.x.
PubMed 18315632Hernández-Cortez E. Update on the management of laryngospasm. J Anesth Crit Care Open Access. 2018;8(2):1-6.
Birlie Chekol W, Yaregal Melesse D. Incidence and Associated Factors of Laryngospasm among Pediatric Patients Who Underwent Surgery under General Anesthesia, in University of Gondar Compressive Specialized Hospital, Northwest Ethiopia, 2019: A Cross-Sectional Study. Anesthesiol Res Pract. 2020 Jan 24;2020:3706106. doi: 10.1155/2020/3706106. eCollection 2020.
PubMed 32411216Oshan V and Robert WM. Anesthesia for complex airway surgery in children. Continuing Education in Anesthesia, Critical care and Pain 2013;13:47-51
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty
- ClinicalTrials.gov ID
- NCT06627660
- Acronym / sponsor ID
- Valsalva for laryngospasm
- Conditions
- Laryngomalacia, Laryngospasm
- Keywords
- VALSALVA MANEUVER, Postoperative Laryngospasm, Supraglottoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Sameh FathyUniversity, hospital or other
- Study start
- 6 Oct 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 4 Oct 2024 (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.
We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.
Primary outcome: Incidence of postoperative stridor and laryngospasm Secondary outcome: incidence of reintubation, postoperative hemodynamics, duration of postoperative ICU and hospital stay
Detailed description
Congenital Laryngomalacia is the main cause of stridor in newborns and infants, affecting 45-75% of all infants with congenital stridor. Short aryepiglottic folds, redundant arytenoid, omega-shaped epiglottis, and inspiratory stridor are features of laryngomalacia. Pediatric laryngospasm is a glottic closure due to reflex constriction of the laryngeal muscles that produce partial or complete obstruction of the larynx. When complete and sustained, laryngospasm is considered an anesthetic Emergency.
The valsalva maneuver involves expiratory effort against a closed glottis in the sitting or supine position with the intraoral and intrathoracic pressures raised to 40 mmHg for 15-20 sec, after which the pressure is suddenly released and the breathing restored to normal.
We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.
After approval of IRB, Mansoura University, this study will be conducted on infants and children ASA I or II aging from 1 month age- 6 years undergoing supraglottoplasty in Mansoura university hospitals. After obtaining a written informed consent from patients parents, random number generator with closed envelope technique will randomize patients into two groups [control] group ( C group ), Valsalva group ( V group)].
Anesthesia will be induced by inhalational induction using sevoflurane at concentration (6:8%). After that, a proper sized cannula will be introduced with giving atropine 0,01mg/kg and hydrocortisone 4mg/ kg. Then, patients will be seen by fiberoptic endoscopy by the surgeon to detect the stage of laryngomalacia and the supraglottic pathology. After that, proper sized ETT will be inserted using succinylcholine 1mg\kg IV and fixed in place after confirmation of correct positioning , with maintenance of anesthesia with isoflurane. All patients will be given 0.5-1mic /kg fentanyl and 15 mg /kg paracetamol.
A pilot study will be done including 5 patients in each study group. The Incidence of postoperative stridor will be used as the primary variable with difference between studied groups was 40% (50% in group C versus 10% in group V). G*power software version 3.1.9.2 will be utilized to detect the required sample size for a study power of 90% and alpha error of 0.05. Cases involved in the pilot study will not be included in the total sample size of the study. Then total sample size will be 26 in each group and by adding 10% to compensate for possible drop out then total sample size per group will be 29 cases in each group. Perioperative data will be tabulated and analyzed using IBM SPSS software version 26.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- INTERVENTIONAL
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –Control group |
| Group V | Active comparator | Procedure: Valsalva maneuverRepeated Valsalva maneuver will be done after recovery from anesthesia |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants and children ASA I or II aging from 1 month age - 6 years undergoing supraglottoplasty
Key exclusion criteria (3 listed)
- Parents refusal.
- Patients with increased ICP
- Patients with increased IOP
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 |
|---|---|---|
| Valsalva maneuverClosure of the nose and mouth during expiration for 20 sec | Procedure or surgery | Group V |
Primary outcome
Incidence of laryngospasm
Time frame: 24 HOURS
4 secondary outcomes
incidence of reintubation
Time frame: 24 HOURS
Postoperative oxygen saturation measurement
Time frame: 1 HOUR
Incidence of postoperative nausea and vomiting
Time frame: 24 HOURS
Duration of postoperative hospital stay
Time frame: 24 HOURS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 29368315Kumar CM, Van Zundert AAJ. Intraoperative Valsalva maneuver: a narrative review. Can J Anaesth. 2018 May;65(5):578-585. doi: 10.1007/s12630-018-1074-6. Epub 2018 Jan 24.
- Background: PubMed 27260594Ramprasad VH, Ryan MA, Farjat AE, Eapen RJ, Raynor EM. Practice patterns in supraglottoplasty and perioperative care. Int J Pediatr Otorhinolaryngol. 2016 Jul;86:118-23. doi: 10.1016/j.ijporl.2016.04.039. Epub 2016 May 3.
- Background: PubMed 18315632Alalami AA, Ayoub CM, Baraka AS. Laryngospasm: review of different prevention and treatment modalities. Paediatr Anaesth. 2008 Apr;18(4):281-8. doi: 10.1111/j.1460-9592.2008.02448.x.
- BackgroundHernández-Cortez E. Update on the management of laryngospasm. J Anesth Crit Care Open Access. 2018;8(2):1-6.
- Background: PubMed 32411216Birlie Chekol W, Yaregal Melesse D. Incidence and Associated Factors of Laryngospasm among Pediatric Patients Who Underwent Surgery under General Anesthesia, in University of Gondar Compressive Specialized Hospital, Northwest Ethiopia, 2019: A Cross-Sectional Study. Anesthesiol Res Pract. 2020 Jan 24;2020:3706106. doi: 10.1155/2020/3706106. eCollection 2020.
- BackgroundOshan V and Robert WM. Anesthesia for complex airway surgery in children. Continuing Education in Anesthesia, Critical care and Pain 2013;13:47-51
- 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. This study is not recruiting at the moment.
Ahmed Elshahat Aboelfoutouh, DOCTORAL DEGREE (MD) principal investigator
Lecturer of Anesthesia and Surgical Intensive Care - Faculty of medicine - Mansoura university
Rania Elmohamady Elbadrawy, DOCTORAL DEGREE (MD) principal investigator
Lecturer of Anesthesia and Surgical Intensive Care- Faculty of medicine - Mansoura university
Questions about this trial
What is this clinical trial studying?
A study testing Valsalva maneuver in people with Laryngomalacia and Laryngospasm, run by Sameh Fathy.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SAMEH FATHY ELSHERBINY, DOCTORAL DEGREE (MD) (002-0100-6500748, SMFSHERBINY@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of laryngospasm (time frame: 24 HOURS). 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 NCT06627660, which also lists 6 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 Oct 2024.