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NCT Number: NCT06627660

Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants and children ASA I or II aging from 1 month age - 6 years undergoing supraglottoplasty

Exclusion criteria

  • Parents refusal.
  • Patients with increased ICP
  • Patients with increased IOP

Treatment and study plan

valsalva maneuver

Procedure

Closure of the nose and mouth during expiration for 20 sec

Primary outcomes

  1. Incidence of laryngospasm

    Time frame: 24 HOURS

Secondary outcomes

  1. incidence of reintubation

    Time frame: 24 HOURS

  2. Postoperative oxygen saturation measurement

    Time frame: 1 HOUR

    Oxygen saturation (%) is recorded every 5 minutes

  3. Incidence of postoperative nausea and vomiting

    Time frame: 24 HOURS

  4. Duration of postoperative hospital stay

    Time frame: 24 HOURS

Study contacts

Contact information is provided by the study sponsor or research team.

SAMEH FATHY ELSHERBINY, DOCTORAL DEGREE (MD)

CONTACT

[email protected]

002-0100-6500748

Sponsors and collaborators

Lead sponsor

Sameh Fathy

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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